Noted This Week

June 14–20

Merck announced that the FDA expanded the indication for pembrolizumab (Keytruda) to include patients with metastatic small cell lung cancer whose disease progressed on or after platinum-based chemotherapy and at least one other therapy. The approval was based on pooled data from two trials in which patients had an objective response rate of 19% and a partial response (PR) rate of 17%. Among 16 responding patients, 94% responded for at least 6 months; 63% responded for at least a year.

At the meeting of the European Hematology Association (EHA), Chinese biotech BeiGene touted encouraging response rates to two of its drugs: the BTK inhibitor zanubrutinib and the PD-1 inhibitor tislelizumab.

  • In a nonrandomized cohort of 26 patients with the MYD88WT genotype of Waldenström macroglobulinemia, five of whom were treatment-naïve, the overall response rate (ORR) to zanubrutinib was 80.8% after a median follow-up of 12.2 months, with 53.8% of patients experiencing a PR or better. Neither progression-free survival (PFS) or overall survival had been reached.
  • Tislelizumab demonstrated an ORR of 87% and a complete response (CR) of 63% among 70 patients with relapsed/refractory classic Hodgkin lymphoma who had an average of three previous therapies. PFS in the phase II trial was estimated at 73.8%, and median PFS had not been reached after a median of 13.9 months of follow-up. The results were slightly better than those presented at the American Society of Hematology Annual Meeting last December.

Also at the EHA meeting, Regeneron announced positive results from early-stage trials of REGN1979, a bispecific monoclonal antibody designed to kill cells by binding to both CD20 and CD3. Four of seven patients with relapsed/refractory diffuse large B-cell lymphoma treated with the drug experienced a CR, including two patients whose disease had progressed after receiving chimeric antigen receptor therapy. In addition, 13 of 14 patients with follicular lymphoma grades 1 to 3a responded to the drug, 10 of whom experienced a CR.

Sanofi announced that it is eliminating 466 jobs in France and Germany and dropping new, in-house research on cardiology drugs. The pharmaceutical giant said that it will commit more resources to cancer, immunology, rare diseases, and vaccines; biologics and gene therapy research will also get a boost. The company plans to keep the job cuts voluntary.

Fighting back against a rule that would mandate the inclusion of drug prices in television ads, Amgen, Merck, and Eli Lilly filed suit against the Department of Health and Human Services. Along with the Association of National Advertisers, the companies argue that consumers generally don’t pay full price for medication due to insurance coverage, so the figures would be misleading—and that the rule impinges on their right to free speech. Set to take effect in July, the rule requires noting list prices for any drug costing $35 or more for a 30-day supply or for a typical course of treatment.


Research Watch