J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers
Today, a brief rundown of news from J&J and the FDA, as well as updates from Sage Therapeutics, Roche and Enanta Pharmaceuticals that you may have missed.
New data from two trials testing Johnson & Johnson’s multiple myeloma drug Talvey could help the company make the case for its use in combination with other medicines. The results were presented at this year’s annual meeting of the International Myeloma Society. In one Phase 1b study, Talvey together with J&J’s Darzalex curbed myeloma growth in 82% of patients with relapsed or refractory disease. In the other, Talvey and J&J’s other new myeloma drug Tecvayli led to complete responses in more than half of myeloma patients given the target dose. — Ned Pagliarulo
Data don’t support use of cancer immunotherapy in certain approved uses for digestive tract cancers, a Food and Drug Administration advisory committee voted Thursday. In gastric cancer and squamous cell esophageal cancer, Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo are approved to treat patients regardless of levels of a protein called PD-L1, while BeiGene has sought approval of Tevimbra in the same setting. The FDA said PD-L1 expression appears to predict whether people with the two cancers will respond, but clinical trials haven’t used the same tests and relied on different thresholds to determine whether people are positive. Asked whether data backed the use of the drugs in people with low PD-L1 levels, the committee, made up of outside advisers to the FDA, voted 10-2 against in the case of gastric cancer and 11-1 against esophageal cancer. — Jonathan Gardner
AbbVie’s acquisition last year of Cerevel Therapeutics may turn out better than expected. While AbbVie bought Cerevel for an antipyschotic called emraclidine, new study results strengthen the evidence behind an experimental Parkinson’s disease medicine known as tavapadon. The data, released Thursday, show tavapadon helped improve patient scores on a symptom rating scale in a second Phase 3 study, five months after the success of the first surprised analysts on Wall Street. More results are due from a third trial by the end of this year. — Ned Pagliarulo
Roche on Thursday said that Gazyva, a medicine it sells for lymphoma, succeeded in a Phase 3 study in a form of lupus that affects the kidneys. Roche didn’t provide details, but said a higher proportion of people with lupus nephritis who received Gazyva and standard therapy as opposed to typical drugs alone had a “complete renal response,” which is associated with the preservation of kidney function, after 76 weeks. Two secondary study goals correlated with disease control were also met, while some others weren’t. The drug is one of several Roche is testing against lupus, among them a pair of so-called T-cell engagers, which have become popular tools in immune drug research. — Ben Fidler
Biogen is terminating an agreement with Sage Therapeutics to license rights to an experimental drug for essential tremor, two months after the companies reported it failed a mid-stage study. In that study, none of the three tested drug doses outperformed placebo after three months of testing. The companies continue to work together on Zurzuvae, a medicine for postpartum depression that won U.S. approval last summer. — Ned Pagliarulo
Biotechnology company Enanta Pharmaceuticals said treatment with its experimental drug for respiratory syncytial virus showed a “rapid and sustained antiviral effect” in a human challenge study. Dubbed EDP-323, Enanta’s candidate is what’s known as an L-protein inhibitor. The company is developing it as a once-daily oral treatment for RSV, which can cause severe disease in infants and older adults. According to Enanta, adverse events were similar between EDP-323 and placebo. — Delilah Alvarado
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