With Roche’s FDA approval on Thursday, both companies’ bispecific antibodies will hit the market this summer for relapsed or refractory diffuse large B-cell lymphoma.
Pictured: T cells attacking and killing cancer cells / iStock, Meletios Verras
Four weeks after competitor AbbVie’s bispecific antibody for lymphoma was approved, the FDA Thursday gave the nod to Roche Group member Genentech’s BsAb for relapsed or refractory diffuse large B-cell lymphoma.
A head-to-head competition is brewing between both companies’ bispecific antibodies as they will hit the market this summer.
Genentech’s Columvi (glofitamab) and AbbVie’s Epkinly (epcoritamab), co-developed with Genmab, are marketed for use in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma. Columvi is also approved for large B-cell lymphoma (LBCL) arising from follicular lymphoma. At the same time, Epkinly is also indicated for DLBCL due to indolent lymphoma and high-grade B-cell lymphoma. All patients must have received at least two prior lines of treatment.
Both drugs were approved under the FDA’s Accelerated Approval Program based on Phase I/II trial results. AbbVie announced in its press release that a confirmatory trial is required to keep Epkinly on the market, while Genentech said its approval “may be contingent” on another successful trial.
The therapies utilize the body’s immune system to kill the lymphoma present in the body. Bispecific antibody design allows simultaneous binding to CD3 on T cells and CD20 on B cells to induce the T cell-mediated killing of CD20+ cells.
Results for the targeted therapies are similar. In the respective Phase I/II trials, 56% of patients achieved an overall response rate and 43% achieved a complete response on Columvi, while Epkinly posted a 61% ORR and 38% CR. The median duration of response was 18.4 months for Columvi versus 15.6 months for Epkinly.
Patients on Genentech’s BsAb will receive a fixed course of 13 intravenous infusions over a maximum of 12 cycles, completed in 8.5 months. AbbVie’s treatment is a subcutaneous injection with an average therapy duration of around nine months, with infrequent dosing after.
Bispecific antibodies can cause cytokine release syndrome (CRS), so both drugs carry a stark warning on the label. The effect can cause fever and trouble breathing along with more serious side effects and can lead to death. Both therapies utilize a step-up dosing schedule to help mitigate the risk of CRS.
AbbVie’s subcutaneous design for Epkinly may give it an advantage in the safety department. Researchers believe that injection under the skin, resulting in slower, steadier absorption than intravenous, may lower the risk of CRS.
Pricing for the therapies is close, with Epkinly at $37,500 per month ($337,500 over nine months) and Columvi at $350,000 for its full course (8.5 months).
Genentech Antibody History
Genentech’s been a player in the antibody market for non-Hodgkin’s lymphoma since Rituxan (rituximab) was approved by the FDA in 1997. The monoclonal antibody was the first approved for the treatment of cancer and the first single agent approved specifically for lymphoma therapy. While initially approved in oncology, the drug later added indications for rheumatoid arthritis and organ rejection.
Rituxan has been a big earner for Roche through the years, but recent sales have waned in the face of biosimilars that began launching in 2019. With over $8 billion in revenue in 2015, sales dropped to less than $3 billion in 2022.
Analysts at Jefferies forecasted a peak of $2.75 billion in sales for AbbVie’s Epkinly while estimating Genentech’s Columvi at $2 billion plus.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
