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).
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)
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