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more than six months, and two have held up more than 84 weeks. The drug is being evaluated in multiple tumor types, not just melanoma. For people who don’t respond to checkpoint inhibitors in melanoma, nothing has proven effective, said CEO Art Krieg. “The FDA told me at a melanoma meeting that this is their position for this population, and that an effective therapy would be eligible for accelerated approval,” he told Xconomy.
—Tesaro (NASDAQ: TSRO) of Waltham, MA, presented the first human data for its checkpoint inhibitor TSR-042, which is being developed for solid tumors with a specific genetic defect known as microsatellite instability-high (MSI-H), which hobbles their ability to repair their own DNA. It’s the same target pembrolizumab was approved to hit in the historic FDA decision last year.
In the Phase 1 GARNET study, 7 of 15 (47 percent) of patients with endometrial cancers and 7 of 24 (29 percent) patients with non-small cell lung cancer responded to treatment. RBC Capital Markets analyst Kennen MacKay wrote that while the data are promising, they are “largely undifferentiated” from pembrolizumab, meaning a “competitive environment” looms if approved.
BAD NEWS IN PHASE 3
—Newlink Genetics (NASDAQ: NLNK) announced early Phase 1 data for its indoximod in brain cancer patients at AACR, but the bigger news came at the end of its press release. Ames, IA-based Newlink is shelving a Phase 3 melanoma study combining indoximod and checkpoint inhibitors pembrolizumab and nivolumab. Indoximod is an IDO inhibitor, a type of drug many companies hope to combine with checkpoint inhibitors to boost immunotherapy response rates. But Newlink is hitting the pause button after a similar effort in melanoma from rival Incyte (NASDAQ: INCY) failed a big Phase 3 trial. Newlink shares fell 16 percent Monday but recovered those losses Tuesday.
—The precipitous fall of Celldex Therapeutics (NASDAQ: CLDX) continues. Two years ago, the company’s cancer vaccine rindopepimut failed a Phase 3 study in brain cancer after encouraging early signs. Now the company is tossing glembatumumab vedotin after failing a mid-stage trial in breast cancer. Hampton, NJ-based Celldex plans to restructure and still has five drugs in clinical trials. But shares now trade at less than $1. They were worth over $30 during AACR three years ago.
Ben Fidler contributed to this report.
Image of acute myeloid leukemia cells courtesy of the National Cancer Institute.