The data, which was presented at the American Society of Clinical Oncology annual meeting, looked into the use of ALLO-501 for relapsed/refractory non-Hodgkin lymphoma.
Today, San Francisco-based biotech company Allogene Therapeutics announced results for its ALLO-501 Phase 1 ALPHA study, along with its development partner, Servier. The data, which was presented at the American Society of Clinical Oncology annual meeting, looked into the use of ALLO-501 for relapsed/refractory non-Hodgkin lymphoma.
ALLO-501 is an anti-CD19 allogeneic CAR T therapy that is being jointly developed by Servier and Allogene. The study also utilized ALLO-647, Allogene’s anti-CD51 monoclonal antibody, as a part of its differentiated lymphodepletion regimen.
“We are very pleased with these initial Phase 1 results, which indicated that ALLO-501 and ALLO-647 were well tolerated and produced complete responses in patients with advanced NHL,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “Based on these results, we believe we are on the right trajectory to make AlloCAR T therapy a reality for patients.”
At the data cutoff time in May 2020, 23 patients were enrolled and 22 patients received ALLO-501. One patient was removed from the trial prior to lymphodepletion as a result of acute renal failure from urinary obstruction. The average time from enrollment to the start of therapy was five days.
To analyze the efficacy of the product, 19 out of 22 patients achieved at least one month assessment as of the May 2020 data cutoff. Their responses were recorded across all cell doses and tumor histologies with an overall response rate of 63% and complete response rate (CR) of 37%.
Higher dose ALLO-647 was associated with a higher CR rate of 50%, deeper lymphodepletion and delayed host T cell recovery. With a median follow-up time of 3.8 months, nine of the 12 responding patients remain in response as of the data cutoff mark.
“Allogeneic CAR T therapies provide an off-the-shelf option that may make cellular therapies available to more patients,” said Sattva S. Neelapu, M.D., Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. “While longer follow-up is required, the response to ALLO-501 appears promising with 75% of patients remaining in response. Together with the positive safety profile, these data suggest that ALLO-501 has the potential to be an effective option if confirmed in future studies.”
This is not the first collaboration that Allogene has entered to further the development of one of its antigen receptor T cell therapies. In January 2020, the company announced that it had entered a clinical trial collaboration agreement with SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing drugs for patients with severe rare diseases and cancer.
The goal of the agreement was to evaluate ALLO-715, Allogene’s investigational anti-B-cell maturation antigen therapy in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, for the treatment of relapsed or refractory multiple myeloma.
“Gamma secretase inhibition has emerged as a clinically validated mechanism to potentiate BCMA therapies and we believe that nirogacestat has the potential to become a cornerstone of BCMA combination therapy for patients with multiple myeloma,” said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. “We are delighted to partner with Allogene, a pioneer in the allogenic cell therapy field, to further explore nirogacestat in combination with an ‘off-the-shelf’ CAR T therapy for these patients where the need for treatment options remains great.”
Allogene is set to sponsor and conduct the Phase 1 study evaluating the safety, tolerability, and preliminary efficacy of the combination, and will assume all development costs. SpringWorks is currently enrolling patients in a global Phase 3, double-blind, randomized, placebo-controlled clinical trial to evaluate the use of nirogacestat in adult patients with progressing desmoid tumors.
