Bristol Myers Squibb (BMY) has announced that Opdivo (nivolumab) plus Yervoy (ipilimumab) demonstrated a significant improvement in overall survival (OS) in patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). This is a rare but aggressive form of cancer that forms in the lining of the lungs, and is frequently caused by asbestos exposure.
With a minimum follow-up of 22 months, treatment with Opdivo plus Yervoy reduced the risk of death by 26%, demonstrating a median OS of 18.1 months vs. 14.1 months for chemotherapy. At two years, 41% of patients treated with the Opdivo plus Yervoy combination were alive, compared to 27% of patients treated with chemotherapy.
The safety profile of Opdivo plus Yervoy in the Phase 3 CheckMate -743 clinical trial was consistent with previously reported studies, and no new safety signals were observed.
The primary endpoint of the randomized Phase 3 trial, which involved 605 patients, was OS in all randomized patients. Key secondary endpoints included objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
“An aggressive cancer with a five-year survival rate of less than 10%, malignant pleural mesothelioma has shown resistance to many clinical treatments,” said Paul Baas, M.D., Ph.D., Department of Thoracic Oncology, Netherlands Cancer Institute.
“Now, for the first time, we have evidence that a dual immunotherapy combination showed a superior, sustained overall survival benefit compared to chemotherapy in the first-line treatment of all types of malignant pleural mesothelioma” he stated, adding that the data supports the potential for nivolumab plus ipilimumab to become a new standard of care.
Indeed, in CheckMate -743, Opdivo plus Yervoy showed improvements in survival across both non-epithelioid and epithelioid MPM, with a larger magnitude of benefit observed in the non-epithelioid subgroup. This is striking because non-epithelioid patients generally experience poorer outcomes.
With the dual immunotherapy combination, median OS was 18.7 months for epithelioid patients and 18.1 months for non-epithelioid patients, compared to 16.5 months and 8.8 months, respectively, with chemotherapy.
Opdivo plus Yervoy is a combination of two immune checkpoint inhibitors, targeting two different checkpoints to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor.
Shares in BMY are down 5% year-to-date, but the stock scores a bullish Strong Buy consensus from the Street. That’s with an average analyst price target of $69 (13% upside potential).
On August 6 JP Morgan’s Chris Schott reiterated his buy rating on the stock, writing 2Q sales were negatively impacted due to unwinding of COVID-19-related stocking in 1Q, reduced new patient starts, and fewer patient visits to physicians.
However the analyst noted that management expects an accelerated resumption of clinical trials in 2H20. “We found the commentary to be comparable to other large-cap biopharma companies this earnings season” Schott wrote. He has a $74 price target on BMY for upside potential of 21%.(See BMY stock analysis on TipRanks).
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