INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
ASH Press Releases
On December 5, 2020, Autolus Therapeutics plc (the Company) issued a press release announcing the presentation of updated data from its
ongoing Phase 1 clinical trial of AUTO1 in adult acute lymphoblastic leukemia (ALL) at the 62nd American Society of Hematology (ASH) Annual Meeting, being held December 5-8, 2020. A copy of the press release is furnished as Exhibit 99.1 attached hereto and is incorporated by reference herein.
Additionally, on December 7, 2020, the Company issued a press release announcing the presentation of additional data from its ALEXANDER trial, a Phase
1/2 clinical trial in relapsed/refractory diffuse large B cell lymphoma (DLBCL), at the 62nd ASH Annual Meeting. A copy of the press release is furnished as Exhibit 99.2 attached hereto and is
incorporated by reference herein.
During a conference call and webcast scheduled to be held at 4:00 pm ET/9:00 pm GMT on December 7, 2020, the
Company management will discuss the data presented by the Company at the 62nd ASH Annual Meeting. The slide presentation for the conference call and webcast is furnished as Exhibit 99.3 hereto and
is incorporated by reference herein.
The information contained in this ASH Press Releases section of the Report on Form 6-K, the press releases furnished as Exhibits 99.1 and 99.2 and the presentation furnished as Exhibit 99.3, shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the Exchange Act), and is not incorporated by reference into any of the Companys filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof,
except as shall be expressly set forth by specific reference in any such filing.
Business Update
The Company recently updated its business information as follows:
AUTO1 Phase 1 Clinical Trial in Adult ALL (ALLCAR19 Trial)
The Company announced updated data from its Phase 1b/2 clinical trial of AUTO1 for the treatment of adult ALL. As of the data
cut-off date of November 12, 2020, 19 patients with r/r ALL had received at least one dose of AUTO1. One additional patient was dosed, who died due to infectious complications assessed as unrelated to
AUTO1. It was observed in the trial that AUTO1 was well tolerated, with no patients experiencing Grade 3 or higher cytokine release syndrome (CRS). Across all 20 patients, three patients, all of whom had high leukemia burden (>50% blasts),
experienced Grade 3 neurotoxicity (NT) that resolved swiftly with steroids.
Of the 19 patients evaluable for efficacy in the trial, 16 (84%) patients
achieved minimum residual disease (MRD)-negative complete response (CR) at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival (EFS) at six and 12 months is 69% and 52%,
respectively. Median EFS and overall survival (OS) has not been reached at a median follow up of 16.9 months (range up to 30.5 months). The EFS and OS data are preliminary considering the small number of patients.
Due to the impact on the trial from the ongoing COVID-19 pandemic, the Company now expects to report the final Phase 1
data from this trial in 2022. The Company is also evaluating the development of AUTO1 for the treatment of primary central nervous system lymphoma, with a potential study start in the first quarter of 2021.
AUTO3 - DLBCL (ALEXANDER Trial)
The Company
announced updated data from its ALEXANDER trial, a Phase 1/2 clinical trial in relapsed/refractory DLBCL. As of the data cut-off date of October 30, 2020, 49 patients in the ALEXANDER trial have been
treated and were evaluable for safety. It was observed in the trial that AUTO3 was well tolerated, with low rates of CRS and NT reported. Across all 49 patients, one case of Grade 3 CRS with primary infusion was observed, and three cases of NT have
been reported, with two patients experiencing Grade 3 or higher NT. None of the patients achieving a 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. No prophylactic measures of any kind have been used to manage patients in the trial.