At ASH, Autolus Therapeutics presented new data highlighting progress on AUTO3, the first-in-human bicistronic CD19 and CD22 CAR, in patients with relapsed/refractory diffuse large B-cell lymphoma and pediatric acute lymphoblastic leukemia.
- Preliminary data on AUTO3 in DLBCL demonstrate safety and feasibilty of CD19 and CD22 dual targeting CAR T
- 90% complete response and 100% overall survival at 12 months in CAR T naive pediatric ALL patients dosed with AUTO3
- Investor call to be held December 9 at 8:30 am ET / 1:30 pm GMT to review data
In the dose escalation phase, 16 patients were treated, with 4 patients dosed at 50 x 106 cells without pembrolizumab; 11 patients were dosed at escalating doses of AUTO3 with pembrolizumab administered at day 14 as follows: 3 at 50 x 106 cells, 4 at 150 x 106 cells, and 4 at 450 x 106 of AUTO3; and 1 patient was dosed with 450 x 106 cells with pembrolizumab administered 1 day before AUTO3 infusion.
Fourteen patients were evaluable at one month. AUTO3 was well-tolerated, with no patients experiencing greater than or equal to Grade 3 cytokine release syndrome with primary infusion and 1 of 14 experiencing Grade 3 neurotoxicity that resolved swiftly with steroids, the compamny said.
There were no pembrolizumab immune-related toxicities and the majority of grade 3 or higher adverse events were hematological.
Across all tested doses 5 patients achieved a complete response, with 4 of 5 complete responses ongoing, the longest at 18 months. All CRs were achieved without need for steroid or tocilizumab-based management of the patients or ICU level care, it added.
Among the 10 CAR T-naive patients, at a median follow-up time of 9.7 months, 9 of 10 patients achieved a complete response, and 8 of 10 achieved complete molecular remission by PCR.
Estimated overall survival at 12 months was 100%. There are 2 ongoing patients in complete molecular remission at 12 and 15 months post-AUTO3 infusion, respectively. The most common cause of relapse was due to loss of CAR T-cell persistence. The median persistence of CAR-T cells in blood was 170 days.
Autolus Therapeutics plc (Nasdaq: AUTL) announced that management will host a conference call and webcast on Monday, December 9, 2019 at 8:30 am ET / 1:30 pm GMT to review clinical data presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition.
To listen to the webcast and view the accompanying slide presentation, please go to https://www.autolus.com/investor-relations/news-events/events.
The call may also be accessed by dialing 866-679-5407 (U.S.) or 409-217-8320 (international) and referencing conference ID 9796038.
After the conference call, a replay will be available for one week. To access the replay, please dial 855-859-2056 (U.S.) or 404-537-3406 (international) and enter conference ID 9796038.
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AUTL stock could soar higher in pre-market trading on Monday, December 9, 2019.