Talvey Shows Promise in Myeloma; FDA Panel Questions PD-1 Use in Gastric Cancers
Key Insights
Johnson & Johnson's Talvey, combined with Darzalex, demonstrated an 82% response rate in relapsed or refractory multiple myeloma (search) patients, showcasing potential in treating the disease.
An FDA advisory committee raised concerns about the use of PD-1 inhibitors like Keytruda and Opdivo in gastric and esophageal cancers with low PD-L1 (search) levels.
AbbVie (search)'s tavapadon, acquired through Cerevel Therapeutics, showed positive Phase 3 results for Parkinson's disease (search), strengthening its potential as a monotherapy.
Johnson & Johnson's Talvey (talquetamab) is showing promise in treating multiple myeloma (search), while an FDA advisory committee has raised concerns about the use of PD-1 inhibitors in certain gastric and esophageal cancers. AbbVie (search)'s tavapadon is also showing positive results in Parkinson's disease (search).
Talvey Demonstrates Efficacy in Multiple Myeloma
New data presented at the International Myeloma Society annual meeting highlighted the potential of Johnson & Johnson's Talvey in combination with other therapies for relapsed or refractory multiple myeloma (search). A Phase 1b study showed that Talvey, when combined with J&J's Darzalex, curbed myeloma growth in 82% of patients with relapsed or refractory disease. Another study revealed that Talvey combined with J&J’s Tecvayli led to complete responses in over half of myeloma patients at the target dose, suggesting high response rates and durable responses, even in triple-class refractory patients with extramedullary disease.
FDA Panel Questions PD-1 Inhibitors in Gastric and Esophageal Cancers
An FDA advisory committee voted against the use of cancer immunotherapies in certain approved uses for digestive tract cancers. Specifically, the committee addressed the use of Merck & Co. (search)’s Keytruda and Bristol Myers Squibb (search)’s Opdivo in gastric and squamous cell esophageal cancer (search), where they are approved regardless of PD-L1 (search) levels. BeiGene (search) has also sought approval of Tevimbra in the same setting. The FDA noted that PD-L1 expression appears to predict response in these cancers, but clinical trials have used inconsistent tests and thresholds. The committee voted 10-2 against the use of these drugs in gastric cancer (search) and 11-1 against their use in esophageal cancer for patients with low PD-L1 levels.
AbbVie's Tavapadon Shows Promise in Parkinson's Disease
AbbVie (search)'s acquisition of Cerevel Therapeutics may prove beneficial, as new data strengthens the case for tavapadon, an experimental Parkinson's disease (search) medicine. Phase 3 trial results demonstrated that tavapadon improved patient scores on a symptom rating scale. This positive outcome follows another successful Phase 3 study, surprising analysts. Additional results from a third trial are expected by the end of the year, further solidifying tavapadon's potential as a monotherapy for Parkinson's disease.
Roche's Gazyva Succeeds in Lupus Nephritis Trial
Roche announced that Gazyva, a medicine used for lymphoma, achieved success in a Phase 3 study for lupus nephritis (search). The study showed a higher proportion of patients with lupus nephritis receiving Gazyva and standard therapy achieved a “complete renal response” after 76 weeks, compared to those receiving standard therapy alone. This renal response is associated with the preservation of kidney function. The trial also met two secondary endpoints related to disease control.