On May 29, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported new data highlighting progress on AUTO3, the company’s CAR T cell therapy being investigated in the ALEXANDER study, a Phase 1/2 study in relapsed/refractory diffuse large B cell lymphoma (DLBCL), during the Annual Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program beginning May 29 (Press release, Autolus, MAY 29, 2020, View Source [SID1234558701]).

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"Data from the ALEXANDER trial of AUTO3, a CD19/CD22 dual-targeting CAR T product candidate in DLBCL have shown a complete response rate of 63% at the recommended Phase 2 dose range with an excellent safety profile," said Dr. Aravind Ramakrishnan, Medical Director, Bone Marrow Transplant and Cellular Therapy Program, Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center. "We are encouraged by the current study results and have begun enrollment in an outpatient cohort to assess how this approach may benefit a greater population of DLBCL patients."

As of the data cut-off date of April 27, 2020, 23 patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 were evaluable for safety and efficacy with a minimum of 28-days follow-up. AUTO3 was well tolerated, with no patients experiencing dose limiting toxicity, and there were no treatment-related deaths. At a dose of ≥ 150 x 106 cells across the 2 dosing regimens for pembrolizumab, a single dose of pembrolizumab on day minus 1 (D-1) or three doses of pembrolizumab starting on day 14 (D14), no patient experienced Grade 3 or higher Cytokine Release Syndrome (CRS) and no patient experienced neurotoxicity of any grade. At these doses, 11 out of 16 patients achieved a complete or partial response (ORR=69%), and 9 out of 16 achieved a complete response (CRR=56%) with all 9 complete responses ongoing at a median follow-up of 3 months (range 1-12 months). Additionally, at the recommended Phase 2 dose range of 150 – 450 x 106 cells with pembrolizumab D-1, 6 out of 8 patients achieved a complete response or partial response (ORR=75%), and 5 out of 8 patients achieved a complete response (CRR=63%).

"We are very pleased with the progression of AUTO3 in DLBCL, combining a high level of complete remissions with a safety profile supportive of outpatient use. We have not seen early relapses from complete remissions and are in the process of confirming the profile at the recommended Phase 2 regimen. Our 20 patient outpatient cohort has started, and the results are expected for the second half of 2020 and will further inform the design of the Phase 2 study," said Dr. Christian Itin, chairman and chief executive officer of Autolus.

Investor call on Monday June 1, 2020
Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the ASCO (Free ASCO Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 4880556. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 4880556.