“The follow-up data from our Phase 1/2 study in patients with MSS-CRC who have received at least two prior lines of therapy continue to demonstrate an association between molecular response and overall survival,” said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. “The median overall survival (MOS) in patients with MSS-CRC that had a molecular response has still not been reached and will now exceed 22 months; an additional four months since our last update in May 2022. This is a notable difference compared to the 6–7-month MOS typically observed in third-line MSS-CRC and the 7.8 month MOS in patients without a molecular response within our study. The clinicopathologic analysis shows MSS-CRC patients who achieve a molecular response do not have high tumor mutation burden, PD-L1 expression or high expression of IFNg-related genes. We are also observing molecular responses in patients with liver metastases, a subset that typically receives little benefit from immunotherapy. The recent publication of GRANITE Phase 1/2 results in Nature Medicine detail the program’s novel approach, and the data to date demonstrate its promise in hard-to-treat, late-line settings. The randomized Phase 2/3 GRANITE study in first-line CRC, where patients generally have more time to mount an immune response, is ongoing and preliminary data are expected in 4Q2023.”
