Bristol Myers Squibb BMY announced positive top-line results from the CheckMate -648 study on Opdivo in combination with chemotherapy.
CheckMate -648 is a randomized phase III study evaluating Opdivo plus Yervoy or Opdivo plus fluorouracil and cisplatin (chemotherapy) against fluorouracil plus cisplatin alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
The study results showed that the combination of Opdivo and chemotherapy demonstrated a statistically significant and clinically meaningful benefit for the primary and secondary endpoints of overall survival (OS) in patients whose tumors express PD-L1 and in the all-randomized patient population at the pre-specified interim analysis.
Also, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1.
While Opdivo plus Yervoy also met the primary and secondary endpoints by demonstrating statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 and in the all-randomized population, the combination did not meet its other primary endpoint of PFS by BICR in patients whose tumors express PD-L1.
Opdivo is already approved for ESCC after prior fluoropyrimidine and platinum-based chemotherapy.
Bristol Myers will evaluate the data from the CheckMate -648 study and share the results with health authorities.
The company’s shares have lost 0.2% in the year so far compared with the industry's decline of 6.5%.
Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy, advanced renal cell carcinoma (RCC), adult patients with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), among others. It is also approved for various indications in combination with Yervoy.
Opdivo, a key drug in the company’s portfolio, returned to growth in the fourth quarter after declining in the third quarter amid stiff competition from Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq in key indications.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Moderna MRNA, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Moderna’s earnings estimates for 2021 have increased to $22.72 from $21.58 in the past 30 days.
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