“Barbenheimer” was a phenomenon impossible to manufacture. But, more than a year later, that hasn’t stopped people from trying to make “Glicked” — or even “Babyratu” — happen. The counterprogramming of “Barbie” and “Oppenheimer” in July 2023 hit a nerve culturally and had the receipts to back it up. Unlike so many things that begin as memes, it transcended its online beginnings. Instead of an either-or, the two movies ultimately complemented and boosted one another at the box office. This combination of images shows promotional art for "Gladiator II," left, and "Wicked." And ever since, moviegoers, marketers and meme makers have been trying to recreate that moment, searching the movie release schedule for odd mashups and sending candidates off into the social media void. Most attempts have fizzled (sorry, “Saw Patrol” ). This weekend is perhaps the closest approximation yet as the Broadway musical adaptation “Wicked” opens Friday against the chest-thumping sword-and-sandals epic “Gladiator II.” Two big studio releases (Universal and Paramount), with one-name titles, opposite tones and aesthetics and big blockbuster energy — it was already halfway there before the name game began: “Wickiator,” “Wadiator,” “Gladwick” and even the eyebrow raising “Gladicked” have all been suggested. “'Glicked' rolls off the tongue a little bit more,” actor Fred Hechinger said at the New York screening of “Gladiator II” this week. “I think we should all band around ‘Glicked.’ It gets too confusing if you have four or five different names for it.” As with “Barbenheimer," as reductive as it might seem, “Glicked” also has the male/female divide that make the fan art extra silly. One is pink and bright and awash in sparkles, tulle, Broadway bangers and brand tie-ins; The other is all sweat and sand, blood and bulging muscles. Both films topped Fandango’s most anticipated holiday movie survey, where 65% of respondents said that they were interested in the “Glicked” double feature. Theaters big and small are also pulling out the stops with movie-themed tie-ins. B&B Theaters will have Roman guards tearing tickets at some locations and Maximus popcorn tubs. Marcus Theaters is doing Oz photo ops and friendship bracelet-making. Alamo Drafthouse is leaning into the singalong aspect (beware, though, not all theaters are embracing this) and the punny drinks like “Defying Gravi-Tea.” This image released by Universal Pictures shows Cynthia Erivo, left, and Ariana Grande in a scene from the film "Wicked." “Rather than it being in competition, I think they’re in conversation,” “Gladiator II” star Paul Mescal said. “This industry needs a shot in the arm. Those films gave it last year. We hope to do it this year.” And the hope is that audiences will flock to theaters to be part of this moment as well. It's a sorely needed influx of could-be blockbusters into a marketplace that's still at an 11% deficit from last year and down 27.2% from 2019, according to data from Comscore. “Competition is good for the marketplace. It’s good for consumers,” said Michael O'Leary, the president and CEO of the National Association of Theatre Owners. “Having two great movies coming out at the same time is simply a multiplier effect.” “Glicked” is currently tracking for a combined North American debut in the $165 million range, with “Wicked” forecast to earn around $100 million (up from the $80 million estimates a few weeks ago) and “Gladiator II” pegged for the $65 million range. “Barbenheimer” shattered its projections last July. Going into that weekend, “Barbie” had been pegged for $90 million and “Oppenheimer” around $40 million. Ultimately, they brought in a combined $244 million in that first outing, and nearly $2.4 billion by the end of their runs. It’s possible “Glicked” will exceed expectations, too. And it has the advantage of another behemoth coming close behind: “Moana 2,” which opens just five days later on the Wednesday before the Thanksgiving holiday. “Glickedana” triple feature anyone? This image released by Paramount Pictures shows Pedro Pascal, left, and Paul Mescal in a scene from "Gladiator II." “These are 10 important days,” O'Leary said. “It’s going to show the moviegoing audience that there’s a lot of compelling stuff out there for them to see.” There are infinite caveats to the imperfect comparison to “Barbenheimer,” as well. “Wicked” is a “Part One.” Musicals carry their own baggage with moviegoers, even those based on wildly successful productions (ahem, “Cats”). “Gladiator II” got a head start and opened internationally last weekend. In fact, in the U.K. it played alongside “Paddington in Peru,” where that double was pegged “Gladdington.” “Gladiator” reviews, while positive, are a little more divided than the others. And neither directors Ridley Scott nor Jon M. Chu has the built-in box office cache that Christopher Nolan’s name alone carries at the moment. The new films also cost more than “Barbie” ($145 million) and “Oppenheimer” ($100 million). According to reports, “Gladiator II” had a $250 million price tag; “Wicked” reportedly cost $150 million to produce (and that does not include the cost of the second film, due next year). The narrative, though, has shifted away from “who will win the weekend.” Earlier this year, Chu told The Associated Press that he loves that this is a moment where “we can root for all movies all the time.” Close behind are a bevy of Christmas releases with double feature potential, but those feel a little more niche. There’s the remake of “Nosferatu,” the Nicole Kidman kink pic “Babygirl” and the Bob Dylan biopic “A Complete Unknown.” The internet can’t even seem to decide on its angle for that batch of contenders, and none exactly screams blockbuster. Sometimes the joy is just in the game, however. Some are sticking with the one-name mashup (“Babyratu”); others are suggesting that the fact that two of the movies feature real-life exes (Timothée Chalamet and Lily-Rose Depp) is enough reason for a double feature. And getting people talking is half the battle. When in doubt, or lacking a catchy name, there’s always the default: “This is my Barbenheimer.” Associated Press journalist John Carucci and Film Writer Jake Coyle contributed reporting. Last summer, Malibu's iconic blonde faced off against Cillian Murphy and the hydrogen bomb in the unforgettable "Barbenheimer" double feature. Copyright 2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission. Receive the latest in local entertainment news in your inbox weekly!OpenAI CEO Sam Altman expressed confidence Wednesday that Elon Musk would not use his proximity to Donald Trump to harm business rivals, calling such actions "profoundly un-American." Speaking at the New York Times DealBook conference, Altman addressed concerns about Musk's announced role heading a new Department of Government Efficiency in the incoming Donald Trump administration, and whether he might use it to favor his own companies. "I may turn out to be wrong, but I believe pretty strongly that Elon will do the right thing," Altman said. "It would be profoundly un-American to use political power to hurt your competitors and advantage your own businesses." Even if there are "lots of things not to like about him... it would go so deeply against the values I believe he holds very dear to himself that I'm not that worried about it." Musk, an OpenAI co-founder who later departed the company, is currently suing Altman's firm and Microsoft, claiming they shifted from the project's original nonprofit mission. He has since launched xAI, reportedly valued at $50 billion, making it one of the world's most valuable startups. Altman said that the court battle was "tremendously sad" and that he once saw Musk as "a mega hero." Musk became a close ally of Trump during his campaign, spending over $100 million to boost his presidential bid and joining him at rallies. Since the election victory, he has been a frequent presence in the Trump transition and was reportedly on the line when Google CEO Sundar Pichai called the president-elect to congratulate him on winning the election. The tycoon's businesses have deep connections with governments -- both in the United States and elsewhere -- and his new position has raised concerns about conflict of interest. During the interview, Altman also lowered expectations for the importance of OpenAI's models achieving artificial general intelligence (AGI), a benchmark of human-level intelligence the company has long set as the goal for its technology. "My guess is we will hit AGI sooner than most people in the world think, and it will matter much less," he said. "A lot of the safety concerns that we and others expressed actually don't come at the AGI moment... AGI can get built. The world goes on mostly the same way," he said. arp/aha Get any of our free email newsletters — news headlines, sports, arts & entertainment, state legislature, CFD news, and more.
100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy SAN DIEGO , Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new frontline data featuring TECVAYLI ® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings. The MajesTEC-5 ( Abstract #493 ) and MajesTEC-4 ( Abstract #494 ) studies establish the potential of TECVAYLI ® for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile. These data were highlighted as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting. 1,2 Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI ® in combination with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone (Tec-DRd) or DARZALEX FASPRO ® , bortezomib, lenalidomide and dexamethasone (Tec-DVRd) as induction therapy in the MajesTEC-5 study. 1 All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10 -5 ) and maintained through cycle 6. 1 "These data from the MajesTEC-5 study build on the growing body of evidence of TECVAYLI combinations that support the potential combinability of TECVAYLI with other effective therapies, demonstrating high rates of MRD-negative responses for evaluable patients with newly diagnosed multiple myeloma," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. "At Johnson & Johnson, our deep expertise and understanding of multiple myeloma has shaped the regimens we're developing, including our bispecific antibodies in new combinations, and we're committed to exploring the full potential of our therapies to improve outcomes for patients." The safety profiles were manageable and consistent with individual safety profiles. 1 No treatment-emergent adverse events (TEAEs) led to study treatment discontinuation or death; cytokine release syndrome (CRS; Grade 1 or 2) occurred in 65 percent of patients. 1 No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). 1 Grade 3/4 TEAEs included lymphopenia (43 percent), neutropenia (57 percent) and infections (35 percent). 1 "There remains opportunity to achieve even deeper and more sustained outcomes for a broader patient population in the frontline setting," said Marc S. Raab , M.D., Heidelberg University Hospital, Germany .* "These data reinforce the potential of TECVAYLI when used in earlier lines and show that TECVAYLI can be leveraged to optimize existing standard regimens in combination." Results from the safety run-in of the Phase 3 MajesTEC-4 study highlighted the potential of TECVAYLI ® to be administered as a maintenance therapy following autologous stem cell transplant (ASCT). 2 MajesTEC-4 is the first study to present data on a B-cell maturation antigen (BCMA) bispecific as monotherapy or combination therapy after ASCT. 2 Low rates of non-hematologic Grade 3/4 TEAEs and discontinuation of treatment due to all TEAEs (5.3 percent) were observed. CRS events were all Grade 1/2, mostly occurring during step-up dosing, and ICANS was not observed. Neutropenia and infections were the most common Grade 3/4 TEAEs. 2 Grade 3/4 neutropenia at 6 months showed a decreased trend in cohorts 2 and 3 with less frequent TECVAYLI ® dosing (cohort 1: 94 percent, cohort 2: 63 percent, cohort 3: 47 percent). 2 A similar trend was observed for all-grade infections (cohort 1: 94 percent; cohort 2: 78 percent; cohort 3: 77 percent). 2 All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6. 2 Further analysis of combination therapies will be evaluated in the Phase 3 MajesTEC-7 study, which is currently enrolling. About MajesTEC-5 Study MajesTEC-5 ( NCT05695508 ) is an ongoing, Phase 2 study of teclistamab and talquetamab, evaluating the safety and efficacy of combination regimens in participants with newly diagnosed transplant eligible multiple myeloma. 3 About MajesTEC-4 Study MajesTEC-4 ( NCT05243797 ) is an ongoing, multicenter, randomized, open-label, Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation. 4 About MajesTEC-7 Study MajesTEC-7 ( NCT05552222 ) is a Phase 3 randomized study comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab SC and lenalidomide (Tal-DR) versus daratumumab SC, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. 5 About TECVAYLI ® TECVAYLI ® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. 6 The European Commission (EC) granted TECVAYLI ® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023 , the EC granted the approval of a Type II variation application for TECVAYLI ® , providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI ® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In February 2024 , the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI ® for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months. For more information, visit www.TECVAYLI.com . About DARZALEX FASPRO ® and DARZALEX ® DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX FASPRO ® is co-formulated with recombinant human hyaluronidase PH20, Halozyme's ENHANZE ® drug delivery technology. DARZALEX ® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX ® -based regimens have been used in the treatment of more than 585,000 patients worldwide and more than 239,000 patients in the U.S. alone. In August 2012 , Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. For more information, visit https://www.darzalexhcp.com. About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 7 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors. 8 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease. 9 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease. 10 People living with multiple myeloma have a 5-year survival rate of 59.8 percent. 11 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections. 12,13 TECVAYLI ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL- ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI ® . Initiate treatment with TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI ® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life- threatening reactions, can occur in patients receiving TECVAYLI ® . Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI ® until neurologic toxicity resolves or permanently discontinue based on severity. TECVAYLI ® is available only through a restricted program called the TECVAYLI ® and TALVEY ® Risk Evaluation and Mitigation Strategy (REMS). INDICATION AND USAGE TECVAYLI ® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). WARNINGS AND PRECAUTIONS Cytokine Release Syndrome - TECVAYLI ® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI ® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI ® . The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI ® accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI ® based on severity. TECVAYLI ® is available only through a restricted program under a REMS. Neurologic Toxicity including ICANS - TECVAYLI ® can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI ® at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI ® . In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI ® at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI ® . The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI ® based on severity per recommendations and consider further management per current practice guidelines. Due to the potential for neurologic toxicity, patients are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI ® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves. TECVAYLI ® is available only through a restricted program under a REMS. TECVAYLI ® and TALVEY ® REMS - TECVAYLI ® is available only through a restricted program under a REMS called the TECVAYLI ® and TALVEY ® REMS because of the risks of CRS and neurologic toxicity, including ICANS. Hepatotoxicity - TECVAYLI ® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Infections - TECVAYLI ® can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%. Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI ® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Monitor immunoglobulin levels during treatment with TECVAYLI ® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Neutropenia - TECVAYLI ® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of patients. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI ® based on severity. Hypersensitivity and Other Administration Reactions - TECVAYLI ® can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue. Local Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI ® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI ® and for 5 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Please read full Prescribing Information , including Boxed WARNING, for TECVAYLI ® . DARZALEX FASPRO ® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS DARZALEX FASPRO ® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation. WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO ® . Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO ® . Systemic Reactions In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO ® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO ® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients. Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO ® . Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO ® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO ® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO ® . Local Reactions In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management. Neutropenia Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO ® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO ® , higher rates of Grade 3-4 neutropenia were observed. Thrombocytopenia Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO ® until recovery of platelets. Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO ® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO ® and for 3 months after the last dose. The combination of DARZALEX FASPRO ® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy. Interference With Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO ® . Type and screen patients prior to starting DARZALEX FASPRO ® . Interference With Determination of Complete Response Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO ® -treated patients with IgG kappa myeloma protein. ADVERSE REACTIONS In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO ® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema. The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO ® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to see the full Prescribing Information for DARZALEX FASPRO ® . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JanssenUS and @JNJInnovMed . Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TECVAYLI ® (teclistamab-cqyv ) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. * Marc S. Raab , M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Raab, Marc, S., et al, 493 Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 2 Zamagni, Elena, et al., 494 Phase 3 Study of Teclistamab (Tec) in Combination with Lenalidomide (Len) and Tec Alone Versus Len Alone in Newly Diagnosed Multiple Myeloma (NDMM) As Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT): Safety Run-in (SRI) Results from the MajesTEC-4/EMN30 Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 3 GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX). https://clinicaltrials.gov/study/NCT05695508 . Accessed November 2024 . 4 Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4). https://clinicaltrials.gov/study/NCT05243797 . Accessed November 2024 . 5 A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7). https://classic.clinicaltrials.gov/ct2/show/NCT05552222 . Accessed November 2024 . 6 U.S. FDA Approves TECVAYLI ® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma . Accessed November 2024 . 7 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178 8 National Cancer Institute. Plasma Cell Neoplasms. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq . Accessed November 2024 . 9 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma . Accessed November 2024 . 10 American Cancer Society. Key Statistics About Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women . Accessed November 2024 . 11 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/ . Accessed November 2024 . 12 American Cancer Society. What is Multiple Myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html . Accessed November 2024 . 13 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html . Accessed November 2024 . Media contacts: Sarah Freeman sfreem21@its.jnj.com Christie Corbett ccorbet6@its.jnj.com Investor contact: Lauren Johnson investor-relations@its.jnj.com U.S. Medical Inquiries +1 800 526-7736 View original content to download multimedia: https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-demonstrates-potential-as-frontline-combination-therapy-for-patients-with-newly-diagnosed-multiple-myeloma-302325575.html SOURCE Johnson & Johnson
PITTSBURGH (AP) — Joey Porter Jr. thrives on the pressure. Read this article for free: Already have an account? To continue reading, please subscribe: * PITTSBURGH (AP) — Joey Porter Jr. thrives on the pressure. Read unlimited articles for free today: Already have an account? PITTSBURGH (AP) — Joey Porter Jr. thrives on the pressure. Wants it. Invites it. Needs it. Pittsburgh Steelers coach Mike Tomlin first noticed it more than a decade ago, when Porter was just a kid running around the team facility while his father, Joey Porter Sr., served as an assistant coach. There was something about the way the younger Porter carried himself, a swagger, that made him stand out and served as a precursor to the professional life that was ahead for the second-year cornerback. Tomlin described it as a “serial killer’s mentality,” though Tomlin’s description of what that actually means isn’t as chilling as it sounds. “He’s not running from the fight, he’s running to the fight,” Tomlin said. “You better have a short memory at that position, and he’s always had it. He was probably nine or 10 when I met him, and he had it then.” It’s one of the reasons the Steelers practically sprinted to the podium to take Porter with the first pick of the second round in the 2023 draft, a full-circle moment for a Pittsburgh native well-versed in the franchise’s history of excellence at one of the most demanding positions on the field. Porter has not been shy about wanting to become known as an elite defender and is unafraid to ask for the toughest assignments, only too aware that things won’t always go his way. Good thing, because of late, they haven’t. Porter has found himself being targeted frequently by opposing quarterbacks, looking to use the 24-year-old’s innate aggressiveness against him. The results have been a steady stream of flags and the referee finishing his call with “No. 24, defense.” Porter found himself on the wrong side of a call four times in last Sunday’s 44-38 victory over Cincinnati as he ping-ponged in between Bengals stars Ja’Marr Chase and Tee Higgins. Twice he was flagged for holding. Twice he was cited for pass interference. It wasn’t ideal, to be clear. It also wasn’t the end of the world. Porter stood at his locker in the aftermath and answered every question, then did the same on Wednesday. Tomlin made it a point to say the issues with Porter are technical, not mental. It’s one of the reasons neither Porter nor his coach seem concerned about one shaky performance bleeding into another, something the first-place Steelers (9-3) can’t afford when Jameis Winston and pass-happy Cleveland (3-9) visit Acrisure Stadium on Sunday. “I’ve just got to keep playing my game and don’t let (the penalties) affect me,” Porter said. Asked if that was easier said than done, Porter nodded. “Definitely,” he said. “Playing DB is a hard position, but you got to have that mentality anyways. That’s the world we live in and I feel like I’m capable of doing that.” In some ways, Porter didn’t really have a choice. Not with his father — one of the most prolific and productive trash-talkers in the NFL during a 13-year career as a linebacker that included four Pro Bowls and a Super Bowl ring he earned with the Steelers in 2005. He preached the virtues of not letting one play, one moment, one game chip away at the confidence necessary to survive in a pass-happy game. “He’d been telling me that since I was a young kid,” Porter said. “I know what I got to do to be great, look good, and to help this team win.” It’s telling that for all the flags against him — Porter has been penalized nine times, tops on the Steelers and tied for second in the league among defensive players — he has yet to allow a touchdown pass in coverage. It’s a tradeoff the Steelers can live with in general. Porter’s 6-foot-2 frame is one of the reasons he was among the most coveted cornerbacks in his draft class. His size is unusual for his position, and necessary given some of the matchups he draws, such as the 6-foot-4 Higgins. “You have to match the physicality of these big people, and sometimes you do so at risk,” Tomlin said. “And that’s just a tightrope that I and he are willing to walk in an effort to be competitive.” There are certain tendencies Porter has noticed on film that he needs to clean up, particularly around the line of scrimmage. The hiccups that have popped up recently are correctable. The problems that could crop up if Porter started doubting his own ability are another matter. He insists that’s hardly the case. “Things happen, you know that,” he said. “I like to bounce back and prove myself again. So that’s what I got to do this upcoming Sunday.” Winnipeg Jets Game Days On Winnipeg Jets game days, hockey writers Mike McIntyre and Ken Wiebe send news, notes and quotes from the morning skate, as well as injury updates and lineup decisions. Arrives a few hours prior to puck drop. He likely won’t lack for opportunities. Winston is coming off a 497-yard performance in a loss to Denver, and the Steelers had trouble keeping Joe Burrow in check in Cincinnati. Winston is not afraid to test opposing cornerbacks. Porter is not afraid to be tested. “I’m trying to be great,” he said. “And I know to do that, I got to clean up with the stuff I’ve been doing. So I just face it and keep working.” NOTES: LB Alex Highsmith (ankle) was limited in practice on Wednesday and is nearing a return after missing the past three games. ... WR Calvin Austin III (concussion) was limited. ___ AP NFL: https://apnews.com/hub/nfl Advertisement AdvertisementIt's been one month since the U.S. presidential election. And while Republicans and President-elect Donald Trump have been busy setting up a new White House administration, Democrats have spent the past four weeks trying to diagnose why they lost and how to move forward as a party. One person who thinks he has an answer to that is Ben Wikler, chairman of the Wisconsin Democratic Party. He's now running to become the new chairman of the national Democratic National Comittee because he says it's time to reassess what matters most to voters. RELATED STORY | DNC chair slams Bernie Sanders' criticism of Democratic Party "There's clearly a lot that we need to learn about what just happened, but one thing that jumps out is that a lot of voters who were taking it on the chin with high prices — frustrated by those prices — weren't hearing from either campaign and were voting for change," Wikler told Scripps News. "Well those voters, I think that we have a chance to reach out to them and say 'look, Democrats actually want to fight for an economy that works for working people and Trump wants to give multi-trillion tax cuts to billionaires at your expense. And that is a message we know can win because it's won downballot, it won in 2018, and it won in 2006 when George W. Bush tried to privatize social security." Meanwhile, the Supreme Court is currently hearing a potentially landmark case on gender affirming care for minors — which has been a big point for Democrats to campaign on. But a Scripps News/YouGov poll released early this year showed that more Americans support than oppose laws aimed at restricting transgender care for minors. RELATED STORY | Scripps News poll: Americans largely support restricting trans rights Wikler told Scripps News that if he were to be named chair of the DNC, it's a no-brainer that he'd support American's right to make their own private medical decisions without worrying about government intervention. "Republicans want to talk about trans issues and go on the attack against trans people because that is their way of trying to divide the public," he said. "People do disagree about this. Republicans want to focus on that disagreement and use attacks on trans people in order to distract folks from the big legislation that they are planning right now — which is a multi-trillion dollar tax cut for billionaires." "Democrats are always going to fight for people to have their basic personal freedom," Wikler continued. "And at the same time, we're going to fight against those who want to dismantle the federal government and the programs like social security and medicare and medicaid that people rely on for their their basic needs and health care." You can watch Scripps News' full interview with Ben Wikler in the video player above.
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