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Bristol Myers wins FDA OK for Opdivo use before surgery in lung cancer

The Food and Drug Administration approved Bristol Myers Squibb's Opdivo for use before surgery in early-stage lung cancer, the latest milestone in drug company efforts to establish immunotherapy treatment earlier in the course of patients' disease.

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The agency cleared a regimen of Opdivo alongside chemotherapy for patients with non-small cell lung cancer whose tumors can be removed surgically. Clinical testing showed treatment reduced the risk of cancer recurrence, disease progression or death by 37% versus chemotherapy alone, though so far it's unclear whether treatment can extend survival as well.

Opdivo's green light follows the agency's October decision to approve Roche's similar drug Tecentriq for use after surgery in lung cancer patients. Merck & Co.'s Keytruda, which in January produced mixed results in a similar setting in a Phase 3 trial, could follow, opening up new ways to treat patients with early-stage disease.

Immunotherapies known as checkpoint inhibitors are now used to treat dozens of tumor types. Their impact has been particularly significant in lung tumors, the leading cause of cancer death in the U.S.

For these patients, immunotherapies from Merck, Roche and Bristol Myers are available for use in combination with chemotherapies or other drugs when tumors have already spread. Each has proven in testing to extend lives over older treatment regimens for people with advanced lung cancer.

In particular, a regimen of Keytruda and chemotherapy has become a preferred option for a majority of patients, having shown it can cut the risk of death almost in half. Lung cancer accounted for the bulk of Keytruda's $17 billion in 2021 sales.

The three drugmakers also have tested their drugs earlier in a patient's disease, both after surgery to remove a tumor (adjuvant) and before (neoadjuvant). The hope is that using these drugs before or after surgery, either with or instead of chemotherapy, will help stop cancers from returning for longer. Studies have shown anywhere from about a third to more than half of non-small cell lung cancer patients who have their tumors surgically removed later experience a recurrence, leaving room for improvement.

All three companies now have some evidence that their drugs can delay cancer recurrence. The FDA approved Roche's Tecentriq in the adjuvant setting based on its ability to reduce the risk of death or disease recurrence by 34% for patients whose tumors express a key protein called PD-L1. Merck's results for Keytruda in January, though mixed, were enough for the drugmaker to submit to regulators.

Bristol Myers' approval, which came just five days after the company said the FDA had accepted its application, allows for Opdivo treatment before surgery, the earliest use for an immunotherapy in lung cancer. The OK is not limited by PD-L1 status, the company said in a statement.

The approval is based on Phase 3 study results that showed patients who received Opdivo and chemotherapy lived a median of almost 32 months without their cancer returning, about a year longer than those treated only with chemo. About a quarter of patients who got Bristol Myers' drug had no trace of cancer on a scan compared to about 2% of those who didn't, according to the FDA's labeling for the drug.

While these results could be a proxy for Opdivo keeping lung cancer patients alive longer, that's not yet proven. Roche didn't have such data in hand when Tecentriq was approved and, while an interim analysis of Bristol Myers' study showed a positive trend in survival, it wasn't statistically significant.

The lack of that data could slow adoption. Oncologists have long debated the importance of so-called event-free survival, a measure drugmakers use to support drug approvals while evidence on overall survival is still being collected. Some physicians have hesitated to use immunotherapies, which can have serious side effects, in early settings without that proof. The drugs also carry six-figure price tags, which could significantly drive up the cost of care for patients.

Bristol Myers said it will present detailed results from its study, called Checkmate-816, at a medical meeting in April.

Published March 7, 2022

Ben FidlerSenior Editor

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