Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the ESMO Virtual Congress 2020
- AUTO3 shows promise of a highly differentiated product profile
Conference call and webcast to be held Friday, September 18, 2020 at 8:00 am EDT / 1:00 pm BST
LONDON, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced new data highlighting progress on AUTO3, the company’s CAR T cell therapy being investigated in the ALEXANDER study, a Phase 1/2 clinical trial in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during the European Society for Medical Oncology (ESMO) Virtual Congress 2020, beginning 18 September.
“Today we presented data from our recommended Phase 2 dose cohort from the ALEXANDER trial of AUTO3, a CD19 and CD22 dual targeting CAR T product candidate in DLBCL. The data support a best in class profile with a high level of complete remissions and a well tolerated safety profile,” said Dr. Christian Itin, chairman and chief executive officer of Autolus.
“AUTO3 has a tolerable and very favorable safety profile when compared with approved CD19 CAR T therapies,” said Dr Craig Moskowitz, Professor of Medicine at Miller School of Medicine, University of Miami Health System. “It has a promising complete response rate of 64%, as demonstrated in the completed cohorts at the recommended Phase 2 dose range and, thus far, these complete remissions also appear durable. Among all dose cohorts with a median follow up of 6 months, 93% of the patients who achieved a complete response did not relapse.”
As of the data cut-off date of August 3, 2020, 35 patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 have been treated and were evaluable for safety. AUTO3 was well tolerated, with no Grade 3 or higher cytokine release syndrome (CRS) with primary infusion and low rates of neurotoxicity (NT). Across all 35 patients, only three cases of NT have been reported, with two having = Grade 3. Among the 20 patients treated at a dose of = 150 x 106 cells with pre-conditioning pembrolizumab on day minus 1 (D-1), which is the declared recommended Phase 2 dose (RP2D), one patient experienced =Grade 3 NT (patient died due to disease progression and multiorgan failure). None of the patients achieving a complete response (CR) experienced any NT and all cases of NT reported have been atypical in nature and seen in a setting with disease progression and confounding factors.
In terms of efficacy data, of the 35 patients dosed to date, 30 patients were evaluable within their completed cohort. The cohort receiving a dose of = 150 x 106 cells and pre-conditioning pembrolizumab D-1 (the RP2D) had an objective response rate (ORR) of 71% and CR rate of 64%. For all patients on study across all dose levels that were evaluable, the ORR was 68% and CR rateof 54%.
Investor call on Friday September 18, 2020
About Autolus Therapeutics plc
Lucinda Crabtree, PhD
Susan A. Noonan