Nuvectis Pharma is terminating development of NXP800 in ovarian cancer after it failed to show promise in a Phase Ia/Ib study.
In the Phase Ib portion of the trial (NCT05226507), the GCN2 kinase activator was investigated in 17 patients with recurrent, platinum-resistant, ARID1a-mutated ovarian cancer who were treated with NXP800 at the target dose of 75 mg/day, administered intermittently or daily, with data available for 13 patients.
Data from 13 patients showed that two patients achieved unconfirmed partial response and three achieved stable disease.
The company will not pursue further development of NXP800 in ovarian cancer but will evaluate the feasibility of development opportunities for NXP800 in other cancer types, such as endometrial and prostate cancers, in which the patients’ performance status and other characteristics may allow treatment with NXP800 to be more impactful.
CEO of Nuvectis, Ron Bentsur, said: “While the Phase Ib data provides evidence that NXP800 is biologically active in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, we have decided to focus our near-term efforts on advancing NXP900.”
Bentsur added: “That said, we believe that NXP800 is an active agent and in the coming months we will evaluate the feasibility of other opportunities in which NXP800 can potentially demonstrate its anti-cancer activity more profoundly.”
Earlier in the study, three patients experienced Grade 4 thrombocytopenia, but Nuvectis has said that with a dosing amendment, while one more case of thrombocytopenia did occur, it was at a lower grade. The adverse event (AE) is now being successfully managed in other patients following the switch to intermittent dosing.
Nuvectis first reported data from the Phase Ib trial in November 2024, where it showed one patient with an unconfirmed partial response and six patients with stable disease, including tumour shrinkage from 11 evaluable patients.
Nuvectis is advancing NXP900 to a Phase Ib trial after dose-limiting toxicity was not reached in a Phase Ia trial (NCT05873686).
GlobalData estimates that the value of the ovarian cancer market across the seven major pharmaceutical markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) will reach $4.05bn by 2032.
GlobalData is the parent company of the Clinical Trials Arena.
Due to minimal early symptoms, many ovarian cancer patients are diagnosed at late stages. The standard of care (SoC) typically involves primary debulking surgery followed by chemotherapy. Recurrence is common, leading to a need for additional treatment options, especially for patients who develop platinum resistance.
There are several clinical trials exploring various mechanisms of action (MoAs) for new therapies to improve patient responses to initial treatments and address the challenges posed by platinum resistance. This includes Eisai’s antibody-drug conjugate (ADC) farletuzumab ecteribulin, which, if approved, would be a competitor to AbbVie’s Elahere (mirvetuximab sorvatansine), an ADC that received approval from the FDA on 25 March 2024.
Corcept Therapeutics is seeking approval of its oral relacorilant with nab-paclitaxe after a Phase III study of the combination met its primary endpoint, demonstrating an improvement in progression-free survival (PFS) in individuals with platinum-resistant ovarian cancer.
MSD also hailed a recent success in ovarian cancer after the Phase III KEYNOTE-B96 trial of Keytruda (pembrolizumab) plus chemotherapy (paclitaxel), with or without bevacizumab, met the primary goal of PFS in platinum-resistant recurrent ovarian cancer patients.
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