- OncoGenex Pharmaceuticals (OGXI -3.5%) announces the results of a Phase 2 study assessing the efficacy of low (600 mg) and high (1000 mg) dose apatorsen in combination with gemcitabine/cisplatin chemotherapy compared to chemotherapy alone in patients with metastatic bladder cancer.
- The 600 mg dose showed a 14% reduction in risk of death and a 17% reduction in progressive disease compared to chemo alone. In a subgroup of patients with lower performance status (Karnofsky score <=80%), low dose apatorsen plus chemo reduced the risk of death 50%.
- Less benefit was observed with the high dose due to a high incidence of adverse events and discontinuation of both apatorsen and chemo. The low dose was well tolerated.
- The company will work with investigators and regulatory authorities to clarify a development path forward.