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SPEAR T-cells Targeting MAGE-A4 Demonstrate New Responses in Esophagogastric Junction (EGJ), Lung, and Head and Neck Cancers – Late Stage Development Initiated in EGJ Cancer | |||||||||||||||||||||||||||||||||||||
By: GlobeNewswire - 29 May 2020 | Back to overview list |
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- New Phase 2 trial in EGJ cancer planned for 1H 2021, after first two patients treated responded to next-generation ADP-A2M4CD8 therapy - - Durability and efficacy data presented at ASCO support potential for SPEARHEAD-1 as a registrational trial for sarcoma - commercial launch planned in the US in 2022 - - Phase 2 trial combining ADP-A2M4 with pembrolizumab in head and neck cancer (SPEARHEAD-2) will be the first time a SPEAR T-cell therapy is used in sequence with first line systemic therapy - - The SURPASS trial (a Phase 1 trial with ADP-A2M4CD8) will focus on lung, EGJ, head and neck, and bladder cancers - - Confirmed complete response in a patient with liver cancer in the Phase 1 ADP-A2AFP trial (reported as partial response in January) - PHILADELPHIA and OXFORDSHIRE, United Kingdom, May 29, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, presented updated data from its ADP-A2M4 Phase 1 trial at the American Society for Clinical Oncology (ASCO) Annual Meeting. The data demonstrate durability and responses in synovial sarcoma, supporting SPEARHEAD-1 as a potential registrational trial. The ASCO presentation also describes a new response in a patient with lung cancer, and a response in a patient with head and neck cancer (reported in January). The Company also announced new responses in the SURPASS trial, confirming the potential for SPEAR T?cell therapies targeting MAGE-A4 to treat a broad range of cancers in addition to sarcoma. These data further support the rationale for two new Phase 2 trials – SPEARHEAD-2 in head and neck cancer, which will begin later this year, and a second trial in esophagogastric junction (EGJ) cancer planned for 1H 2021. A webcast of Dr. Elliot Norry, Adaptimmune’s Chief Medical Officer, and Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer, summarizing these and other clinical data is available here: https://bit.ly/3enqBBy. “I am pleased to announce that we have identified a new indication to progress into late stage development. We plan to initiate a Phase 2 trial in esophagogastric junction cancer in the first half of 2021, with our next-generation ADP-A2M4CD8 SPEAR T-cells. In addition, the ASCO data demonstrate promising durability for ADP-A2M4 in sarcoma bolstering our ambition to have our first marketed therapy in 2022,“ said Adrian Rawcliffe, CEO. “I’m thrilled with the responses in a broad range of tumors with our programs targeting MAGE-A4 and AFP. I am confident that we will be able to identify more indications for late stage development as more patients are treated in our trials.” During an oral presentation at ASCO, Dr. David Hong of the MD Anderson Cancer Center reported positive durability and efficacy data in synovial sarcoma from the ADP-A2M4 Phase 1 trial. Based on these data, the Company believes that SPEARHEAD-1 can support registration for ADP-A2M4. These positive data also supported removal of the futility analysis from SPEARHEAD-1, reducing the sample size from 60 to 45 patients. Outside of sarcoma, Dr. Hong shared a new RECIST response in a patient with lung cancer, as well as the response in a patient with head and neck cancer reported earlier this year. Further, he reported evidence of anti-tumor activity in ovarian cancer, bladder cancer, and melanoma. In the SURPASS trial, three patients have responded out of the first four treated with ADP-A2M4CD8. One patient with EGJ cancer treated in the first dose cohort had a confirmed partial response (PR) reported in January, which remains ongoing approximately six months post-infusion. As reported today, a second patient in the first dose cohort, also with EGJ cancer, has an unconfirmed PR. The third response in the trial is an unconfirmed PR in a patient with head and neck cancer. Data from this trial will be updated and presented in the second half of 2020 at a medical conference. Based on these data, the Company plans to initiate a Phase 2 trial in EGJ cancer in the first half of 2021. In January, the Company reported one confirmed PR in a patient with liver cancer from the ADP?A2AFP Phase 1 trial. Subsequently, this PR has been assessed as a confirmed complete response, which remained ongoing at the last assessment (Week 24). The next two patients with liver cancer (or hepatocellular carcinoma [HCC]) treated in Cohort 3 did not respond. A separate cohort for AFP expressing tumors other than HCC was initiated and the one patient treated to date has not responded. Detailed data will be presented in a poster and an oral presentation at the International Liver Congress (ILC) in August 2020 (rescheduled from April of this year). RECIST Responses with SPEAR T-cell Monotherapy in Patients with Late Stage Cancers*
a: n=number of patients treated; b: includes one unconfirmed PR; c: patient treated in radiation sub-study of ADP?A2M4 Phase 1 trial; d: previously assessed as PR ADP-A2M4 clinical update
Other trials in the MAGE-A4 program SURPASS
SPEARHEAD-2
ADP-A2AFP clinical trial
About Adaptimmune Forward-Looking Statements Adaptimmune Contacts: Media Relations: Sébastien Desprez — VP, Communications and Investor Relations Investor Relations: Juli P. Miller, Ph.D. — Senior Director, Investor Relations |
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Copyright 2020 GlobeNewswire | Back to overview list |