Kymriah, the second-line treatment of Novartis for lymphoma, has suffered a setback in the phase 3 BVELINDA clinical study to confirm its efficacy by failing to meet the primary endpoint.

On Wednesday (local time), Novartis released its updates on the BELINDA study of Kymriah on patients who had relapsed aggressive B-cell non-Hodgkin lymphoma or had shown a lack of improvements after first-line treatment.

Compared to the treatment with standard of care (SOC), Kymriah failed to meet the primary endpoint of event-free survival (EFS).

BELINDA study is a multicenter, open-labeled, and randomized phase 3 clinical trial. It is an important study that compared the drug's tolerance, efficacy, and safety by comparing it with SOC, salvage chemotherapy that followed high-dose chemotherapy, and hematopoietic stem cell transplant (HSCT), according to the company.

“Patients with aggressive B-cell non-Hodgkin lymphoma who are refractory to first-line treatment are vulnerable, and we are disappointed that the BELINDA study did not meet its primary endpoint in this setting,” said Jeff Legos, executive vice president and global head of oncology & hematology development at Novartis.

Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting, he added.

“We remain committed to accelerating the development of Kymriah and our next-generation CAR-Ts and anticipate sharing early clinical results for these therapies at an upcoming medical meeting.” Legos said

Novartis said it would cooperate with investigators to analyze the results further while completing the BELINDA data evaluation.

According to industry insiders, Gilead Sciences and BMS have reportedly attained positive data from their studies, heralding intensified competition in the field of B-cell non-Hodgkin lymphoma (NHL).