Study flags rare heart risk for Bristol cancer combo
- A new article published this week in the New England Journal of Medicine suggests immune checkpoint inhibitors, a fast-growing and promising class of drugs, could lead to potentially fatal heart damage in a very small percent of patients.
- Researchers reported that two patients with melanoma have died from severe inflammatory responses which affected the heart after receiving treatment with Bristol-Myers Squibb's Yervoy (ipilimumab) and Opdivo (nivolumab)
- Both patients developed myositis with rhabdomyolysis and myocarditis with a high level of T cell infiltrates, which the researchers indicate could be tied to drug treatment. However, pharmacovigilance data reviewed in the article shows myocarditis occurred in only 0.27% of patients treated with the Yervoy/Opdivo combo.
Checkpoint inhibitors have understandably been hailed as a potential game-changing class of drugs for the treatment of some cancers. Bristol-Myers' Opdivo and Merck's Keytruda, both of which block a protein known as PD-1, have quickly gained traction and racked up hundreds of millions in sales.
Bristol-Myers, which has paired Opdivo with its older CTLA-4 inhibitor Yervoy, has dominated the market so far. Yet Opdivo's major trial miss in first-line non-small cell lung cancer (NSCLC) this summer will likely give Merck the opportunity it needs to move ahead, especially after Keytruda won approval in that indication.
Visiongain estimates the checkpoint inhibitor market will be worth $16.55 billion by 2020. Opdivo, Keytruda, and Roche's Tecentriq (atezolizumab) will likely be the major players but dozens of drugmakers are also looking at combination therapies pairing those drugs with other agents.
The combination of Opdivo and Yervy has given patients with melanoma longer-progression-free survival and higher objective response rates than Yervoy (ipilimumab) alone.
But the findings in NEJM indicate physicians may have to consider the potential for heart-related adverse events when starting patients on checkpoint inhibitor combinations. Still, the researchers emphasized the findings were not aimed at undermining the drugs, but instead to shed light on safety to improve treatment.
Even so, its likely not news Bristol-Myers wants to hear after seeing its edge in NSCLC evaporate.
- New England Journal of Medicine Fulminant Myocarditis with Combination Immune Checkpoint Blockade
- The New York Times Lifesaving cancer drugs may in rare cases threaten the heart
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