On May 31, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, to treat advanced solid tumors (Press release, Gritstone Oncology, MAY 31, 2022, View Source [SID1234615261]). Additionally, the company announced it is presenting a "Trial in Progress" poster summarizing the Phase 2/3 GRANITE-CRC-1L- study (randomized study for first-line maintenance treatment of metastatic, microsatellite stable colorectal cancer) at the 2022 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"The updated OS data from our Phase 1/2 study continue to demonstrate a correlation between molecular response and overall survival, and points to the potentially significant impact GRANITE is having on lives of patients with advanced stage cancer," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "The median overall survival observed in multiple trials of various therapies in the third-line MSS-CRC setting has been around 6-7 months, which is consistent with what we observed in our study in patients who did not have molecular response (median overall survival of 7.8 months). The very different outcome observed in the molecular responder subset, with median overall survival of over 18 months, is all the more striking given how rarely long-term survival is observed in MSS-CRC patients who have been treated with and progressed on two prior therapies. These maturing data, demonstrating long-term clinical benefit, further support moving GRANITE upstream in the treatment of patients with this grim cancer in the ongoing randomized Phase 2/3 study, which has registrational intent."

The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, Opdivo (nivolumab) and subcutaneous anti-CTLA-4 antibody, Yervoy (ipilimumab) in advanced solid tumors. This study enrolled and treated 26 patients as of ESMO (Free ESMO Whitepaper) 2021 presentation with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. As presented at ESMO (Free ESMO Whitepaper) 2021, of 9 patients with MSS-CRC who were treated and evaluable for molecular response, 4 experienced a molecular response (as evidenced by a reduction in circulating tumor DNA [ctDNA]) and continue to have an OS advantage compared to those patients who did not have a molecular response.

Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.

Updated overall survival data from GRANITE Phase 1/2:

4 of 9 treated patients with MSS-CRC had a molecular response (as reported during the ESMO (Free ESMO Whitepaper) 2021 data presentation) and the observed median overall survival in this group will now exceed 18 months (median OS not yet reached versus 7.8 months in those who did not have a molecular response).
All patients with MSS-CRC assessed for molecular response and alive at the time of the ESMO (Free ESMO Whitepaper) 2021 data presentation remain alive after an additional 35 weeks of follow-up.
ASCO presentation details are as follows:

Abstract TPS3635: Phase 2/3, randomized, open-label study of an individualized neoantigen vaccine (self-amplifying mRNA and adenoviral vectors) plus immune checkpoint blockade as maintenance for patients with newly diagnosed metastatic colorectal cancer (GRANITE)
Date/Time: Saturday 04 June 2022, 8:00am CST
Session: Gastrointestinal Cancer – Colorectal and Anal
Location: Poster 425b