Tanja Obradovic: New Phase III trial with an innovative MOA may soon change the standard of care for second-line MSS CRC
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“New Phase III trial with innovative MOA that has significant potential to change standard of care in advanced colorectal cancer (CRC) for patients with microsatellite stable (MSS) disease in the second-line may be coming soon.
Leap Therapeutics just announced very promising results from the Part B of the DeFianCe study evaluating Sirexatamab (DKN-01) in combination with Bevacizumab and chemotherapy as a second-line treatment.
Sirexatamab is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKK1 is a secreted inhibitor of beta-catenin-mediated Wnt signalling. Low expression of DKK1 indicates the abnormal activation of the Wnt pathway and is related to the poor prognosis of patients with CRC.
Based on DeFianCe study analysis where ORR was almost doubled by treatment vs standard of care several patient populations may be benefiting and are evaluated for inclusion into planned PhIII trial(s): DKK1 biomarker-selected, anti-VEGF naive, anti-EGFR experienced, or RAS-wt patients.
Considering very different possibilities for the trial design for these populations it will be of interest to see if only one or multiple PhIII trials open in the future.
Interesting to point is that Sirexatamab will not continue development into PhIII in gastric cancer after inconclusive efficacy in a Phase II DisTinGuish study where it was tested with Tislelizumab, BeiGene’s anti-PD-1 antibody.”
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