Syndax Pharmaceuticals Inc (NASDAQ:SNDX) has announced disappointing phase 3 clinical study results of E2112. ECOG-ACRIN Cancer Research Group has conducted the phase 3 clinical trial for Syndax on E2112 in 608 patients. In phase 3 clinical trial, ECOG-ACRIN has examined Syndax’s class I HDAC inhibitor together with exemestane in patients suffering from HR+, HER2- breast cancer. Syndax has not achieved the primary endpoint for this formulation to exhibit improved overall survival benefit over hormone therapy.
Conveys sincere thanks to all the patients
Briggs W. Morrison, CEO of Syndax, said that using exemestane and entinostat, could not help achieve primary endpoint of improving survival benefit of breast cancer patients. Syndax will not submit an IND application to the FDA for metastatic breast cancer because the results are not positive.
The cancer, which is originated in the breast, spreads to one or more locations in your body like bones, liver or lungs is called metastatic breast cancer. Several companies are engaged in innovative therapies to improve the survival rate of patients.
Around 276,480 women in the US are expected to get diagnosed with invasive breast cancer. The drugs already approved to cure breast cancer include Anastrozole, Abemaciclib, Capecitabine, and Ixabepilone.
Advances broader portfolio
Briggs said the company will continue to advance its broader portfolio that comprises axatilimab and SNDX-5613. The company expects to release additional clinical data later this year from its Augment-101 clinical study of the SNDX-5613 conducted in adults suffering from refractory/ relapsed acute leukemias. The recent phase 1 results and preclinical data reported as of date represent the first clinical evidence that shows that inhibiting Menin-MLL1 interaction can induce a response in the patients with genetically defined acute leukemia.
Syndax is confident that SNDX-5613 can provide an effective treatment option for patients suffering from MLL-r acute leukemias and NPM1 mutant acute myeloid leukemia. The company also expects to provide additional results from its ongoing phase 1/2 study of the axatilimab in patients suffering from chronic graft versus host disease in Q4 2020.
Gives importance to patients and employees safety
Syndax maintains safety and health of medical professionals, patients and its employees during coronavirus crisis with no impact on its ongoing clinical studies and financial guidance.