Bristol Myers Squibb BMY announced encouraging results from the CheckMate -816 study on Opdivo (nivolumab) for the treatment of non-small cell lung cancer (NSCLC).
CheckMate -816 is a phase III randomized, open-label, multi-center trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable NSCLC.
Results from the study showed that neoadjuvant treatment with three cycles of Opdivo plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa NSCLC. pCR is defined as no evidence of cancer cells in their resected tissue, as assessed by a blinded independent pathology review. Data showed that 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR compared to 2.2% of patients treated with chemotherapy alone.
Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of the disease. Opdivo plus chemotherapy also demonstrated improvements in key secondary endpoints, including major pathological response (MPR).
The study data also showed more patients who received neoadjuvant Opdivo plus chemotherapy underwent surgery (83% vs. 75% with chemotherapy), showing that the addition of Opdivo did not decrease the feasibility of performing surgery. In addition, the number of patients whose tumors were completely resected was higher with Opdivo plus chemotherapy vs. chemotherapy alone (83% vs. 78%). Rates of surgery-related adverse events were similar between the two treatment arms.
The data reinforce the efficacy of the Opdivo-based treatment regimens, which have also demonstrated durable survival in advanced thoracic cancers. CheckMate -816 data show that an Opdivo plus chemotherapy regimen has the potential to improve long-term clinical outcomes in earlier stages of NSCLC.
The company’s shares have gained 0.9% in the year so far against the industry's decline of 6.8%.
Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic 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-based therapies have now demonstrated positive results in phase III trials in earlier stages of four different types of cancer — NSCLC, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Label expansion of the drug will further boost sales.
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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