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Sanofi, AbbVie and Genmab Celebrate Mid-Phase Trial Wins


AbbVie and Genmab announced positive topline results from their Phase I/II trial on an investigational antibody for relapsed and refractory large B-cell lymphoma.

Initial results from the first cohort of the Epcore NHL-1 study covered 157 patients who were given epcoritamab (DuoBody -CD3xCD20), a subcutaneous bispecific antibody treatment candidate for cancer. To be eligible for the trial, the participants should have had two or more prior lines of systemic treatments. 38.9% of participants had undergone chimeric antigen receptor (CAR) T-cell therapy.

Topline data showed an overall response rate of 63.1% as observed by an independent review committee. The median duration of response was 12 months. The three most common adverse events included cytokine release syndrome (49.7%), pyrexia (23.6%) and fatigue (22.9%), in addition to anemia, neutropenia, neutrophil count reduction and thrombocytopenia. AbbVie and Genmab are co-developing epcoritamab as part of the companies’ broader oncology collaboration deal.

“Together with our partner, AbbVie, we will work with regulatory authorities to determine next steps and continue to evaluate epcoritamab in a variety of clinical trials as a potential treatment option for patients with various hematological malignancies,” commented Genmad CEO Jan van de Winkel, Ph.D., in a statement.

Meanwhile, Sanofi, working with scientists from Massachusetts General Hospital, posted positive results from its Phase I/II dose-finding trial on rilzabrutinib as a treatment for adults with heavily-treated immune thrombocytopenia (ITP).

Researchers in the Phase III LUNA3 trial demonstrated rilzabrutinib’s safety and potential to rapidly and durably increase platelet counts. Sanofi is evaluating the efficacy and safety of giving 400 mg of rilzabrutinib to adolescents and adults diagnosed with chronic ITP.

ITP is an acquired autoimmune blood disorder characterized by thrombocytopenia, which then predisposes a person to a higher risk of hospitalization, bleeding, poor quality of life and death. There are currently no standard treatments recommended for ITP.

Rilzabrutinib is an oral Bruton’s tyrosine kinase inhibitor that incorporates Sanofi’s Tailored Covalency technology to discover treatments for immune-mediated disorders, including ITP. It has not yet been evaluated by any regulatory authority.

“These findings demonstrate a clinically meaningful response in difficult-to-treat ITP patients who received a median of four prior ITP therapies. Moreover, the overall study population, which also included less refractory patients, showed a numerically higher response. Rilzabrutinib could become a first-in-class BTK inhibitor therapy with the potential to increase platelet counts quickly and durably for people with ITP,” noted Dietmar Berger, M.D., Ph.D., the global head of clinical development and chief medical officer at Sanofi.

Rilzabrutinib received a Fast Track designation in November 2020 from the U.S. Food and Drug Administration. Prior to that, it was granted an orphan drug designation.