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Mashup Score: 46
Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. The observed adverse events of Opdivo with CCRT followed by Opdivo plus Yervoy were generally consistent with the known profiles of each component in the regimen. “Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting,” said Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb. “There remains a critical need to improve long-term outcomes for these patients and we believe these results will help inform future drug development efforts in this
Source: news.bms.comCategories: General Medicine News, Hem/OncsTweet
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Mashup Score: 46
Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. The observed adverse events of Opdivo with CCRT followed by Opdivo plus Yervoy were generally consistent with the known profiles of each component in the regimen. “Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting,” said Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb. “There remains a critical need to improve long-term outcomes for these patients and we believe these results will help inform future drug development efforts in this
Source: news.bms.comCategories: General Medicine News, Hem/OncsTweet
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Mashup Score: 46
Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. The observed adverse events of Opdivo with CCRT followed by Opdivo plus Yervoy were generally consistent with the known profiles of each component in the regimen. “Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting,” said Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb. “There remains a critical need to improve long-term outcomes for these patients and we believe these results will help inform future drug development efforts in this
Source: news.bms.comCategories: General Medicine News, Hem/OncsTweet
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Mashup Score: 32U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase) - 8 day(s) ago
Application based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor The FDA assigned a target action date of February 28, 2025 Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “ subcutaneous nivolumab ”) across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The FDA
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 10
Application based on results from the CheckMate -8HW study, in which Opdivo plus Yervoy demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to investigator’s choice of chemotherapy European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy ® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). The EMA’s validation of the application confirms the submission is complete and begins the EMA’s centralized review process. “Colorectal
Source: news.bms.comCategories: General Medicine News, PayerTweet-
#MEDIA: @EMA_News has validated our Type II variation authorization application for our #immunotherapy combination as a first-line treatment for adult patients with microsatellite instability-high or mismatch repair deficient metastatic #colorectalcancer. https://t.co/6Gk1sOdHTP https://t.co/ThZKRORI92
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Mashup Score: 52
Recommendation based on results from CheckMate -901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard-of-care chemotherapy alone in cisplatin-eligible adults with unresectable or metastatic urothelial carcinoma If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU A decision on the EU marketing authorization is expected by June 2024 Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC
Source: news.bms.comCategories: General Medicine News, Hem/OncsTweet
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Mashup Score: 12
Recommendation based on results from CheckMate -901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard-of-care chemotherapy alone in cisplatin-eligible adults with unresectable or metastatic urothelial carcinoma If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU A decision on the EU marketing authorization is expected by June 2024 Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 29
Bristol Myers Squibb will utilize Cellares’ proprietary Cell Shuttle, a next-generation end-to-end, fully automated cell therapy manufacturing platform, for the clinical and commercial-scale manufacturing of select CAR T cell therapies Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the U.S., EU and Japan for Bristol Myers Squibb’s use This agreement strengthens Bristol Myers Squibb’s existing global network of state-of-the-art cell therapy manufacturing facilities and provides increased agility, improved scalability and potential to improve turnaround time to support the company’s CAR T inline and pipeline assets Bristol Myers Squibb (NYSE: BMY) and Cellares , the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today announced a
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 23
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program Bristol Myers Squibb (NYSE: BMY) today announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI ® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC). These late breaking data (abstract #CT013) will be featured in an oral presentation at the 2024 American Association for Cancer Research (AACR) annual meeting on Monday, April 8 at 11:10 a.m. Pacific Time and will be highlighted as part of the meeting’s official press program. The data will also be published simultaneously in Cancer Discovery . With a median follow up of 11.9 months in 94 patients, KRAZATI plus cetuximab demonstrated an objective response rate, the primary endpoint, of
Source: news.bms.comCategories: General Medicine News, PayerTweet
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Mashup Score: 16
KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment A majority of patients (65%) experienced reductions in weight over the course of the trial, with a mean weight decrease of 2.6kg observed at one year Data show no significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia. These data were presented in a poster titled, “Long-Term Safety of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F74) and in the Oral Session “Long-Term Metabolic Outcomes Associated With KarXT
Source: news.bms.comCategories: General Medicine News, PayerTweet
More sad news: this trial is negative for PFS. @JeffBradleyMD @KaramLab https://t.co/WYIc0xr88m https://t.co/EhT0SfgrRq