One Good, One Bad News For Bristol Myers Squibb's Marketed Drugs: Details

Thursday, Bristol Myers Squibb & Co BMY announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE trial program of Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. 

The study did not meet its primary endpoint of clinical remission at Week 12.

The safety profile of Zeposia in this study was consistent with that observed in previously reported trials. 

The company will complete a full evaluation of the YELLOWSTONE trial data.

Zeposia is approved for relapsing forms of multiple sclerosis and adults with moderately to severely active ulcerative colitis.

Today, Bristol Myers Squibb announced results from the Phase 3 KRYSTAL-12 study, evaluating Krazati (adagrasib) as a monotherapy for pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation.

The study met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR).

The study remains ongoing to assess the additional key secondary endpoint of overall survival. 

Results showed that Krazati demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients. 

Krazati had no new safety signals, and the safety data was consistent with the known safety profile.

The FDA granted accelerated approval for Krazati as a targeted treatment for patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy in 2022. 

In 2023, the Medicines and Healthcare Products Regulatory Agency granted conditional marketing authorization for Krazati as a targeted treatment option for KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy followed by the European Commission in 2024.

In February, the FDA accepted for priority review for the supplemental new drug application for Krazati in combination with cetuximab for previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer. The FDA assigned a PDUFA goal date of June 21, 2024.

Zai Lab Limited ZLAB obtained exclusive rights to develop and commercialize adagrasib in Greater China from Mirati Therapeutics in 2021. Bristol Myers acquired Mirati Therapeutics for $58.00 per share in cash.

Price Action: ZLAB shares are up 0.37% at $16.08, and BMY is down 0.68% at $53.86 on the last check Monday.

Illustration of Phrama lab worker created with MidJourney