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got chemo alone. The regimen also showed a “positive trend”—but not statistical significance—towards the study’s other main goal, event-free survival: Keytruda-chemo cut the risk of disease progression by 37 percent after a median of 15.5 months.
Merck is discussing the Phase 3 data with regulators, talks that could expand the use of immunotherapy in breast cancer.
Seattle Genetics (NASDAQ: SGEN) is best known for its lymphoma drug brentuximab vedotin (Adcetris), a type of medicine that links an antibody to a tumor-killing toxin. At ESMO, another SeaGen treatment with a similar construct showed promise in a Phase 1b study for advanced bladder cancer. Paired with Keytruda, enfortumab vedotin led to a 71 percent response rate among 45 patients, “more than double” what would be expected from immunotherapy alone, SVB Leerink analyst Andrew Berens wrote in a research note.
With encouraging early results from another drug, tucatinib, combined with Herceptin in colorectcal cancer patients, SeaGen shares climbed more than 12 percent to all-time highs.
—Immunotherapy’s impact has been profound in lung cancer, where a regimen of Keytruda and chemotherapy, for instance, has become the first option for a majority of patients with the most common form of the disease, non-small cell lung cancer (NSCLC).
At ESMO and in the New England Journal of Medicine, Merck rival Bristol-Myers Squibb (NYSE: BMY) tried to make the case for their in-house, chemo-free combination of ipilimumab (Yervoy) and nivolumab (Opdivo) to treat first-line NSCLC patients. Analyst Daina Graybosch of SVB Leerink wrote in a research note that the combo would most likely target chemo-intolerant patients, but with the caveat that Bristol’s Yervoy is well known for having its own rough side effect problems.
—Pfizer (NYSE: PFE) bought Array Biopharma in June for $11 billion in large part because of a first peek at the Phase 3BEACON study in metastatic colorectal cancer, which was first reported in May. BEACON got a late-breaking update at ESMO and published results in the NEJM.
—Roche had a lot at stake with its presentation of bladder-cancer results at ESMO. Its immunotherapy Tecentriq nabbed its first approval in bladder cancer in 2016, but many questions remained after a 2017 failure.
Earlier this year, topline data from the Tecentriq IMVigor130 study, revealed nearly two months ago, touted positive progression-free survival, as Evaluate reported here. But it wasn’t the full picture. At ESMO, an analysis in overall survival provided a complicated picture, with patients whose tumors have higher expression of the protein PD-L1 faring much better than patients with low or no PD-L1 expression. Evaluate has more.
Alex Lash contributed to this report.
“Park Guell Lizard” by Ed Menendez via Creative Commons.