The pressure to perform is building for Affimed as its investigational lymphoma treatment fails to beat current standard-of-care treatments, prompting the German biotech to pursue a new path for its lead asset.
The new clinical findings come from Affimed’s mid-stage trial assessing its bispecific antibody AFM13 among patients with CD30-positive, heavily pretreated, advanced-stage peripheral T cell lymphoma (PTCL). The findings were presented at the American Association for Cancer Research (AACR) Annual Meeting in Florida yesterday.
The phase 2 study evaluated antitumor activity among 108 patients, split into three cohorts by level of CD30 expression. Patients received 200 mg of AFM13 via weekly intravenous infusion, with disease assessments occurring every eight weeks for the first two evaluations and every 12 weeks after that.
The final results reveal a median overall survival (OS) rate and progression-free survival (PFS) similar to currently approved therapies in the indication, at 13.8 months for OS and 3.5 months for PFS. The company touts “robust activity” with a 32.4% objective response rate and 10.2% complete response rate (CR) in the intent-to-treat population—which was an estimated 145 participants—though statistical significance was not met.
When stratified by PTCL subsets, patients with angioimmunoblastic T cell lymphoma (AITL) had the highest objective response rate at 53.3% and a complete response rate of 26.7%, though the DoR wasn’t meaningfully different across differing subsets.
“The strong activity of AFM13 in heavily pretreated patients with peripheral T cell lymphoma is very encouraging and, coupled with the favorable safety profile, provides a rationale for further clinical development of the agent in PTCL,” Won Seog Kim, M.D., Ph.D., hematology-oncology professor at Samsung Medical Center in Seoul and principal investigator for the study, said in an April 16 release. “PTCL is a disease that can be challenging to treat with an urgent need for new mechanisms, as there are very few options today. AFM13 holds promise to address the gap in current treatment options.”
Beyond the company’s optimistic take is the fact that the oncology space is highly crowded, whittling down the need for a comparable therapy. Perhaps this is why the German biotech has decided to no longer pursue accelerated approval for AFM13 as a monotherapy in PTCL, instead turning its resources to study AFM13 in combination with Artiva’s AB-101 natural killer (NK) cell product.
The biotech is already running a phase 1/2 trial of AFM13 in combo with allogeneic NK cells. The study demonstrates that the combo type can “achieve remarkable clinical outcomes” for patients with CD30-positive lymphomas, Affimed CEO Adi Hoess, M.D., Ph.D., said April 16.
The clinical-stage company desperately needs a win after falling out of compliance for 30 days with NASDAQ’s $1 per share requirement earlier this month, according to an April 6 filing with the Securities and Exchange Commission. The company has 180 days—or until Oct. 2 of this year—to get its share price back up. Currently, the stock sits at 79 cents per share, up 5% from 75 cents at market close Friday.
That’s not where Affimed’s troubles end though. Last summer, the FDA denied the biotech’s request to launch human trials for its investigational acute myeloid leukemia (AML) med, a move that prompted the company to explore development outside the U.S.
While the FDA didn’t disclose why it denied authorization for the med, known as AFM28, Affimed said it was related to the design of the dose-escalation study and not the asset itself. The bispecific medicine targets CD16A on NK cells and macrophages, and CD123 on leukemia blasts and leukemic stem cells that occur with AML.