Dive Brief:
- Roche’s new dual-acting blood cancer drug Columvi combined with chemotherapy helped people with a type of lymphoma live longer than people given Rituxan and chemo, the company said Monday. The data could help Roche persuade the Food and Drug Administration to convert Columvi’s conditional OK into a full approval.
- Roche didn’t disclose full data from the Phase 3 “Starglo” trial in people with diffuse large B-cell lymphoma whose disease advanced after initial treatment and who weren’t eligible for stem cell transplants. The results will be presented at an upcoming medical meeting, the company said.
- Columvi is a new type of drug called a “bispecific” antibody that triggers an immune response to cancer cells. A competitor developed by Genmab and AbbVie has also gained accelerated approval and could have confirmatory data later this year, while the FDA rejected a bispecific from Regeneron because its confirmatory trial isn’t far enough advanced.
Dive Insight:
Columvi is conditionally cleared to be used alone in people with lymphoma after two lines of therapy, based on how well it spurred remission and how long patients continued to respond to it in earlier studies. However, that testing didn’t compare the drug to another treatment or a placebo.
Showing the drug can keep people alive longer than a comparative regimen is the FDA’s gold standard for cancer treatment. In a separate trial, lymphoma patients given the comparative therapy, Rituxan plus gemcitabine and oxaliplatin, led to a median overall survival of 10 months.
In addition to submitting the new data for presentation at a medical meeting, Roche said it is filing them with health authorities for approval.
Submission could help Roche gain an edge over Genmab and AbbVie’s drug, Epkinly, which has been evaluated across four late-stage trials in lymphoma. The earliest completion date listed for the Phase 3 Epkinly studies is December 2024, according to a federal database of clinical trials. That study compares Epkinly to chemotherapy regimens including the Rituxan-based one.
Columvi and Epkinly were both approved in 2023 and posted sales of $65 million and $17 million, respectively.
Regeneron has been seeking to catch up to Roche, Genmab and AbbVie, advancing its own bispecific medicine called odronextamab. With a full approval of Columvi potentially pending, accelerated approval for odronextamab could be in jeopardy because of FDA rules around the process.
“Our discussions with the FDA remain ongoing and we remain committed to working closely with the FDA and investigators to bring odronextamab to patients as quickly as possible,” a Regeneron spokesperson said in an email.
These bispecific drugs also compete with cell therapies from Gilead Sciences and Bristol Myers Squibb. Those drugs, sold as Yescarta and Breyanzi, offer lasting remission following a single treatment, but are complicated to manufacture because they are engineered from patients’ own cells. They can also carry significant side effects.
