J&J Advocates for Talvey; FDA Committee Raises Concerns About PD-1 Medications in Specific Cancer Treatments

In this article, we provide a summary of recent updates from Johnson & Johnson, the FDA, along with news from Roche, Enanta Pharmaceuticals, and Sage Therapeutics that may have escaped your notice.

Recent findings from two studies on Talvey, a multiple myeloma drug developed by Johnson & Johnson, may bolster the case for its combined use with other therapies. The findings were shared at the annual meeting of the International Myeloma Society. In one Phase 1b trial, the combination of Talvey and J&J’s Darzalex successfully inhibited the growth of myeloma in 82% of patients with relapsed or refractory disease. Meanwhile, in another study, Talvey in conjunction with Tecvayli yielded complete responses in over half of treated myeloma patients. — Ned Pagliarulo

An FDA advisory committee determined that evidence does not support the application of cancer immunotherapy for certain digestive tract cancers. Specifically for gastric and esophageal squamous cell cancers, Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo have existing approvals that are not dependent on PD-L1 protein levels. Meanwhile, BeiGene is seeking approval for Tevimbra in a similar context. The FDA concluded PD-L1 expression is a predictor of responsiveness to these therapies, but clinical trials did not standardize testing and varied in threshold definitions. In votes on the use of these drugs for low PD-L1 levels, the committee voted 10-2 against for gastric and 11-1 against for esophageal cancer. — Jonathan Gardner

Following last year’s acquisition of Cerevel Therapeutics, AbbVie may be positioned better than anticipated. Though the focus was on an antipsychotic called emraclidine, fresh study results are lending credence to a Parkinson’s disease candidate named tavapadon. Newly reported results from a second Phase 3 trial show improvement in patient scores on a symptom rating scale, following an earlier unexpected success. Additional results are anticipated from a third trial by year-end. — Ned Pagliarulo

Roche announced that its lymphoma treatment Gazyva achieved success in a Phase 3 trial for lupus affecting the kidneys. While specific data remain undisclosed, Roche indicated a greater percentage of patients with lupus nephritis experienced a “complete renal response” when treated with Gazyva along with standard therapy, compared to typical medications alone after 76 weeks. The study also met two of its secondary goals correlating with disease control. Roche is continuing to explore various treatments for lupus, including a range of innovative T-cell engagers that are gaining popularity in immune drug research. — Ben Fidler

Sage Therapeutics announced the termination of its partnership with Biogen concerning an experimental essential tremor treatment, just two months after a failed mid-stage study where none of the three doses outperformed placebo. Despite this, the companies remain partners in the development of Zurzuvae, a treatment for postpartum depression that gained FDA approval last summer. — Ned Pagliarulo

Meanwhile, biotechnology firm Enanta Pharmaceuticals reported that treatment with its experimental respiratory syncytial virus drug demonstrated a “marked and sustained antiviral effect” in a human challenge study. Known as EDP-323, this candidate functions as an L-protein inhibitor and is being designed as a once-daily oral medication for RSV, which poses a heightened risk for infants and the elderly. Enanta’s findings indicate that adverse events were comparable between EDP-323 and the placebo group. — Delilah Alvarado