Onconova Therapeutics, Inc. Announces Encouraging Clinical Data Supporting the Anti-Cancer Activity of Rigosertib-Nivolumab Combination in Advanced KRAS+ Non-Small Cell Lung Cancer
September 22, 2021 at 08:00 am EDT
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Onconova Therapeutics, Inc. announced preliminary safety and efficacy data from an investigator-initiated Phase 1/2a trial of oral rigosertib plus the immune checkpoint inhibitor nivolumab in advanced KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC). The data, which are being featured in a presentation at the 3rd Annual RAS Targeted Drug Development Summit, support the potential anti-cancer activity of rigosertib-nivolumab combination therapy in this indication and show that the doublet has been well tolerated to-date. Three quarters of patients enrolled in the trial have failed two or more lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations. Demographics: All enrolled patients (12/12) failed at least one line of prior therapy with a PD-1 checkpoint inhibitor (includes evaluable and non-evaluable patients). 9 of 12 (75%) enrolled patients failed at least two prior lines of therapy. Response Results: 2 of 7 (29%) evaluable patients achieved a partial response (PR). PRs were observed in patients with two distinct KRAS mutations (G12C, G12V). 3 of 7 (43%) evaluable patients achieved disease control (PR or stable disease). 4 of 7 (57%) evaluable patients experienced progressive disease. Adverse Event Results: The combination of rigosertib and nivolumab has been well tolerated and the maximum tolerated dose has not been reached to-date. Treatment related adverse events were mostly mild with two grade 3 adverse events. 3 patients discontinued study drug (2 grade 2 genitourinary toxicities, 1 dose limiting grade 3 hyponatremia). No unexpected safety events or synergistic toxicities have been observed. This Phase 1/2a trial is designed to evaluate the combination of rigosertib and nivolumab in advanced KRAS+ metastatic NSCLC patients who have progressed on standard of care with anti-PD-1 monotherapy or anti-PD-1 in combination with chemotherapy. It includes a dose-escalating Phase 1 portion followed by a Phase 2a dose-expansion portion. Patients in the trial receive oral rigosertib twice daily on days 1-21, and intravenous nivolumab on days 1 and 15 of 28-day cycles. The primary endpoints of the trial are safety assessments to determine maximum tolerated dose and overall response rate. Secondary endpoints include progression free survival and overall survival.
Traws Pharma, Inc., formerly Onconova Therapeutics, Inc., is a virology and oncology company. The Company is engaged in developing antivirals for influenza, COVID and other respiratory infections and narazaciclib. Its proprietary portfolio includes, TRX100 (viroksavir), TRX01 (travaltrevir), and Narazaciclib. Viroksavir is a cap-dependent endonuclease inhibitor for influenza. Travaltrevir is a Mpro protease inhibitor for COVID19. Narazaciclib is a cyclin-dependent kinases (CDK) 4/6 inhibitor for low-grade endometrioid endometrial cancer (LGEEC). Narazaciclibâs mechanism of action in LGEEC is validated by phase II studies with other approved CDK4/6 inhibitors: palbociclib, ribociclib, and abemaciclib. Narazaciclib is in phase I/IIa study to define the Phase II dose (RP2D).
Onconova Therapeutics, Inc. Announces Encouraging Clinical Data Supporting the Anti-Cancer Activity of Rigosertib-Nivolumab Combination in Advanced KRAS+ Non-Small Cell Lung Cancer