Preliminary Phase 1/2a trial data show an early signal of activity in extensively pre-treated population with 2 partial responses out of 7 evaluable patients
Responses were seen in patients with different KRAS mutations
Data supports further development of rigosertib, in combination with immune checkpoint inhibitors in KRAS mutated (KRAS+) non-small cell lung cancer
Management hosting webinar with key opinion leaders to discuss data today at
Key data from the presentation include:
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
“Combining rigosertib with the immune checkpoint inhibitor nivolumab has been well tolerated and notably led to partial responses in 29% of evaluable patients who had previously progressed on prior checkpoint inhibitor therapies,” said Rajwanth Veluswamy, M.D., Assistant Professor, Medicine, Hematology and Medical Oncology,
Slides from the presentation titled, “Phase 1/2 Trial of Rigosertib & Nivolumab in KRAS-Mutated NSCLC in 2nd+ Line” will be available on the “Scientific Presentations” section of the Onconova website following the conference.
Webinar Featuring Expert Overview from Key Opinion Leaders
Onconova will host a webinar today,
To attend the webinar, click here. A replay of the webinar will be available by visiting the investors and media page on Onconova’s website at www.onconova.com and clicking on the webcast link.
About the Investigator-initiated Phase 1/2a Trial
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. For more information on the trial, see ClinicalTrials.gov Identifier: NCT04263090.
About
Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in
Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.
For more information, please visit www.onconova.com.
Forward-Looking Statements
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