Possible Treatment for CRC Shows Promise

New trial results of Exelixis’ cabozantinib in colorectal cancer are encouraging for further development of the biopharma’s XL902 in the indication, noted an H.C. Wainwright & Co. report.

New available results for two cohorts, one each from two studies evaluating Exelixis Inc.’s (EXEL:NASDAQ) cabozantinib in advanced colorectal cancer, were reported by H.C. Wainwright & Co. analyst Michael King.

As for the CAMILLA trial, 29 of the 36 enrolled Cohort 2 patients were evaluable. Among those the disease control rate was 86.2%, and median overall survival was 9.1 months. Median progression free survival (PFS) was 3.6 months, and PFS at six months was 34.5%.

Twelve evaluable patients in Cohort 2 had a wild type RAS gene. In this group, the disease control rate was 83.3%. Median progression free survival was 6.3 months. Median overall survival was 21.8 months.

Eleven participants had grade 3 or higher treatment-related adverse events (TRAEs), the most common of which included grades 1 to 2 fatigue (53%), nausea (42%), and diarrhea (36%). A fewer number of patients experienced grade 3 or higher immune-related adverse events. One patient discontinued durvalumab due to emergent adverse events.

For Cohort 16 of the COSMIC-021 trial, the primary endpoint was investigator assessed overall response rate. That was 10% (31 patients) at a median follow-up at 28.1 months. Wild type RAS patients had an overall response rate of 25%, whereas RAS mutated patients did not have any objective responses.

The most frequent TRAEs were diarrhea (52%), fatigue (42%), and nausea (35%). Grades 3 and 4 TRAEs occurred in 52% of patients, of which the most often occurring were hypertension (10%), fatigue (6%), and increased lipase (6%). Because of TRAEs, 6% of patients discontinued the double agent regimen, and 6% discontinued the single agent.

King concluded: “Clinical data generated from the COSMIC-021 and CAMILLA trials provide robust rationale to continue developing XL092 in novel combinatorial approaches and in an expansive repertoire of tumors, where cabozantinib has demonstrated meaningful clinical anti-tumor activity, in addition to efficacy.”

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Disclosures for H.C. Wainwright & Co. LLC, Exelixis Inc., Jan. 19, 2022

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