- AbbVie and Genmab said treatment with their dual-acting antibody epcoritamab led to responses in nearly two-thirds of patients with lymphoma, announcing on Wednesday that their clinical trial surpassed its benchmark for success. The partners will now take the data to the Food and Drug Administration and other regulators to determine whether it's good enough to formally submit for approval.
- The data comes from a trial testing epcoritamab in several types of lymphoma. The results reported Wednesday were from patients treated with at least two rounds of drugs, including a large number who had had their disease relapse after receiving cell therapies like Gilead's Yescarta or Novartis' Kymriah.
- Epcoritamab is competing with two Roche dual-acting drugs to become the first approved product of their type in lymphoma. One Roche drug, mosunetuzumab, has been submitted to European regulators in a different kind of lymphoma.
Yescarta and Kymriah, known as CAR-T therapies, can help cancer patients by arming their immune cells to attack diseased tissue in types of lymphoma and leukemia. But, because the immune cells must be genetically engineered outside the body, treatment is lengthy, complicated and expensive.
The dual-acting, or "bispecific," antibodies being developed by AbbVie and Genmab, Roche, and other companies like Johnson & Johnson and Regeneron, latch onto proteins on both diseased and immune cells to trigger an attack. Unlike CAR-T drugs, which are meant to be a one-time infusion, bispecific antibodies must be given regularly. In the case of this epcoritamab trial, patients received a subcutaneous shot every four weeks.
Data from 157 patients with large B cell lymphoma reported Wednesday showed that 63% responded to treatment with epcoritamab, although the company didn't detail how many were driven into remission versus experiencing partial responses. In order to be included in the trial, patients had to have relapsed after at least two lines of therapy. Nearly 40% had previously received CAR-T treatment.
Side effects included a type of inflammatory response called cytokine release syndrome, which is also common with CAR-T. Around half of the patients taking epcoritamab had this side effect, although it tended to be milder than with CAR-T — only 2.5% of patients had a case that didn't respond to symptomatic treatment or brief interruption of the drug.
Kennen MacKay, an analyst at RBC Capital Markets, wrote in a Dec. 15 note that the low severity didn't require patients to be pre-treated with preventive steroids, a potential advantage over CAR-Ts.
The trial did not test epcoritamab against a placebo, meaning researchers weren't able to measure the drug's comparative benefit. Should the FDA agree to review it based on this data, it would likely only be for an "accelerated" approval that would have to then be confirmed with positive results from a controlled trial.
Still, the data revealed so far indicate it measures up well against other bispecific drugs from Regeneron and J&J being tested in large B cell lymphoma, which have led to treatment responses in around 40% of patients. Roche's mosunetuzumab, which was submitted to regulators in a condition called follicular lymphoma, had a 68% response rate in a trial that combined it with another Roche drug called Polivy.
A separate Roche bispecific called glofitimab spurred responses in 41% of patients with B cell lymphoma in a Phase 1 trial.
Biogen recently paid Roche $30 million to opt-in to a development and commercialization deal on mosunetuzumab.