ONTX - Onconova rigosertib/Opdivo combo shows promise in advanced lung cancer in trial

Onconova Therapeutics ( NASDAQ: ONTX ) said updated data from a phase 1/2a trial of oral rigosertib and Bristol-Myers Squibb's ( NYSE: BMY ) Opdivo (nivolumab) showed early signs of efficacy in  certain extensively pre-treated patients with non-small cell lung cancer (NSCLC).

The company reported data the European Society for Medical Oncology (ESMO) Congress 2022.

Three out of 14 evaluable patients achieved an objective response. One patient achieved a complete response (CR), with complete resolution of the primary lung tumor and sites where disease had spread, the company said in a Sept. 12 press release.

Onconova added that two patients saw a partial response (PR). Responses were also seen in patients with three distinct KRAS mutations (CR: KRAS G12V; PRs: KRAS G12C/STK11 and Q61H/STK11).

The mean duration of response was 6.75 months and Four of 14 evaluable patients achieved disease control, according to the company.

Onconova noted that one dose limiting toxicity of grade 3 hyponatremia (low sodium level in blood) was seen (previously observed with rigosertib). Urinary toxicities seen with rigosertib were the most common treatment-related adverse events (TRAE).

The drug combo was generally well tolerated and TRAE were mostly mild and manageable, the company added.

"The evidence of efficacy observed in the trial’s highly challenging population suggests rigosertib may synergize with ICI and potentially provide clinical benefit to patients with limited therapeutic options," said Onconova President and CEO Steven Fruchtman.

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