Bristol Myers Nabs FDA Green Light For Mesothelioma Drug Combo

Bristol Myers Squibb (BMY) has announced that Opdivo plus Yervoy has been approved by the U.S. Food and Drug Administration (FDA) for first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).

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Mesothelioma is a rare but aggressive form of cancer that often forms in the lining of the lungs, with approximately 3,000 cases diagnosed in the US each year.

This approval is based on a pre-specificied interim analysis from the Phase 3 CheckMate -743 trial in which Opdivo + Yervoy demonstrated superior overall survival (OS) versus the platinum-based standard of care chemotherapy.

At two years, 41% of patients treated with Opdivo + Yervoy were alive versus 27% with chemotherapy. Serious adverse reactions occurred in 54% of patients receiving Opdivo + Yervoy.

“Malignant pleural mesothelioma is a rare cancer with limited treatment options. When it is diagnosed in advanced stages, the five-year survival rate is approximately 10 percent,” said study investigator Anne S. Tsao, M.D.

“The survival results from the CheckMate -743 trial show that [this] combination… could become a new front-line standard of care option. This is exciting news, instilling hope for patients” she added.

Indeed, this is the third indication for an Opdivo + Yervoy-based combination in the first-line treatment of a form of thoracic cancer.

Opdivo + Yervoy is a unique combination of two immune checkpoint inhibitors that features a potentially synergistic mechanism of action, targeting two different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells.

Shares in BMY are down 8% year-to-date, but the stock scores a bullish Strong Buy Street consensus. That’s with 7 recent buy ratings vs just 1 hold rating. Meanwhile the average analyst price target stands at $70 (19% upside potential).

“We see BMY on track for solid long-term growth due to a healthy pipeline. Inrebic, a novel myelofibrosis drug, was approved in August, while 6 more novel approvals are expected until the end of the year” commented CFRA analyst Sel Hardy.

With a $70 price target on the stock, Hardy told investors: “We think the stock offers considerable upside and we maintain our positive outlook as we see the Celgene deal creating a faster-growing company with a less concentrated drug portfolio despite the emergence of the Covid-19 pandemic.” (See BMY stock analysis on TipRanks)