Gritstone bio has announced positive preliminary results from the Phase 2 portion of its ongoing Phase 2/3 study of the cancer vaccine, GRANITE. The study concentrates on front-line metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC).
The early data points to favorable progression-free survival (PFS) for patients treated with GRANITE. In the overall population, the hazard ratio was 0.82 (95% CI, 0.34-1.67; 62% censored). Within a high-risk group, the hazard ratio was even lower at 0.52 (95% CI, 0.15-1.38; 44% censored), signifying a relative risk reduction of 48% in progression or death. More than 90% of these high-risk patients presented liver metastases, indicating that this population has more mature clinical data.
The study also revealed interesting insights regarding circulating tumor DNA (ctDNA). The short-term molecular response, as defined by the protocol, was difficult to interpret due to an unpredicted persistent drop in ctDNA beyond induction chemotherapy. However, long-term ctDNA responses revealed trends that parallel PFS trends, favoring GRANITE recipients over control patients.
GRANITE, a personalized cancer vaccine, is being studied as a potential treatment option for front-line metastatic MSS-CRC. The promising preliminary findings from this phase of the study suggest that GRANITE might affect the outcomes positively for MSS-CRC patients, especially those in high-risk groups. Despite short-term molecular results proving difficult to understand, the long-term ctDNA responses show potential. With additional research and more mature data to come, GRANITE might prove to be a significant step forward in the battle against cancer.
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