Bristol Myers Squibb Provides Update on Phase 3 ODYSSEY-HCM Trial

Bristol Myers Squibb announced that its Phase 3 ODYSSEY-HCM trial for Camzyos (mavacamten) in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its dual primary endpoints. These included improvements from baseline at 48 weeks in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2), compared to placebo.

While the trial did not show efficacy in nHCM, no new safety issues were observed. The findings reaffirm the distinct nature of obstructive versus non-obstructive HCM and highlight the need for alternative treatment strategies in the latter.

Camzyos remains approved in the U.S., EU, and over 50 global markets for the treatment of symptomatic obstructive HCM (oHCM), where clinical trials and real-world data continue to support its safety and effectiveness.

The ODYSSEY-HCM trial enrolled 580 patients globally and is the first Phase 3 study of a cardiac myosin inhibitor in non-obstructive HCM. Bristol Myers Squibb plans to share full trial results with the scientific community in the future.

FDA Approves Opdivo Plus Yervoy as First-Line Treatment for MSI-H/dMMR Unresectable or Metastatic Colorectal Cancer

The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a first-line treatment for adults and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This approval is based on the Phase 3 CheckMate-8HW trial, which showed the combination significantly reduced the risk of disease progression or death.

In the first-line setting, the Opdivo-Yervoy regimen reduced progression risk by 79% versus chemotherapy. Across all lines of therapy, it showed a 38% reduction compared to Opdivo alone. Notably, median progression-free survival (PFS) was not reached in the combination group, while it was 5.8 months with chemotherapy. The approval was granted more than two months ahead of the expected FDA decision date.

The combination also demonstrated a higher overall response rate (71%) compared to Opdivo monotherapy (58%), with a manageable safety profile and no new safety concerns identified. Serious adverse reactions occurred in 46% of patients on the combination regimen, with common side effects including fatigue, diarrhea, and pruritus.

Colorectal cancer remains one of the most diagnosed cancers in the U.S., with increasing incidence among younger adults. Approximately 7% of patients with metastatic colorectal cancer have MSI-H/dMMR tumors, which often respond poorly to standard chemotherapy.

This marks the ninth gastrointestinal cancer indication for Opdivo-based therapy. It expands the prior accelerated approval of Opdivo plus Yervoy from second-line to first-line treatment for MSI-H/dMMR metastatic colorectal cancer.

For more information, visit [www.bms.com](https://www.bms.com).

Bristol Myers Squibb announced positive results from the Phase 3 POETYK PsA-2 trial, showing that Sotyktu (deucravacitinib) significantly improved symptoms in adults with psoriatic arthritis (PsA) compared to placebo. At week 16, 54.2% of Sotyktu-treated patients achieved an ACR20 response, indicating at least a 20% improvement in disease symptoms, versus 39.4% on placebo. The treatment also led to greater improvements in skin symptoms (PASI 75) and quality of life.

Sotyktu was well tolerated, with a safety profile consistent with previous studies. The trial included an apremilast reference arm for safety comparison, with no new safety concerns identified. Adverse events occurred in 62.8% of Sotyktu patients compared to 54.7% on placebo and 73.3% on apremilast.

Sotyktu, an oral TYK2 inhibitor, is already approved for moderate-to-severe plaque psoriasis and is being evaluated for broader applications in immune-mediated diseases. Bristol Myers Squibb plans to present further POETYK PsA trial data at upcoming medical conferences and discuss results with regulatory authorities.

Bristol Myers Squibb (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The application has been granted Breakthrough Therapy Designation and Priority Review status, with a Prescription Drug User Fee Act (PDUFA) target action date set for June 23, 2025.

The FDA’s acceptance is based on results from the Phase 3 CheckMate -8HW trial, which demonstrated that Opdivo plus Yervoy achieved superior progression-free survival compared to both Opdivo monotherapy and investigator’s choice of chemotherapy. The combination therapy has already received regulatory approvals for similar indications in the European Union and China in late 2024.

Mismatch repair deficiency (dMMR) and microsatellite instability-high (MSI-H) tumors affect approximately 5-7% of metastatic colorectal cancer patients. These patients typically do not respond well to conventional chemotherapy and often have poorer prognoses, making immunotherapy-based treatments a crucial alternative.

Bristol Myers Squibb’s application brings the company one step closer to establishing a new standard of care for MSI-H/dMMR mCRC. The CheckMate -8HW study continues to evaluate secondary endpoints, including overall survival.

**Source: Bristol Myers Squibb, "FDA Accepts Bristol Myers Squibb’s Supplemental Biologics License Application for Opdivo® Plus Yervoy®," February 24, 2025.**

Bristol Myers Squibb - Bristol Myers Squibb Announces Opdivo® Plus Chemotherapy as the First and Only Neoadjuvant-Only Immuno-Oncology Therapy to Demonstrate Statistically Significant and Clinically Meaningful Overall Survival in Resectable Non-Small Cell Lung Cancer

Bristol Myers Squibb - Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a First-Line Treatment Option for Adult Patients with Unresectable or Advanced Hepatocellular Carcinoma

Bristol Myers Squibb announced results from the Phase 3 CheckMate -8HW trial evaluating the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) versus Opdivo monotherapy in treating microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC). At a median follow-up of 47 months, the combination therapy demonstrated a 38% reduction in the risk of disease progression or death compared to monotherapy, with a higher progression-free survival rate and overall response rate. The safety profile of the combination therapy remained consistent and manageable.

The findings, presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium and published in *The Lancet*, reaffirm the efficacy of dual immunotherapy for this patient group. The study continues to evaluate secondary endpoints such as overall survival. These results build on prior data showing the superiority of the combination therapy over chemotherapy, which previously led to its approval in Europe for first-line treatment in MSI-H/dMMR mCRC patients.