Nuvectis Pharma (NASDAQ: NVCT) has reported encouraging interim data from its Phase 1b study of NXP800, a drug candidate designed to treat platinum-resistant, ARID1a-mutated ovarian cancer. This type of cancer is known for its poor prognosis and limited treatment options, so any sign of disease stability or tumor reduction is a significant step forward. The latest data reveal stable disease in several patients and some tumor shrinkage—an early indication of NXP800’s potential as a therapeutic option.
Encouraging Tumor Activity at Reduced Doses
The Phase 1b results show that NXP800 demonstrates single-agent activity, with six patients achieving stable disease and one showing an unconfirmed partial response, including tumor shrinkage in some cases. Given the high-risk, heavily pre-treated nature of this patient population, this evidence of anti-tumor activity is particularly notable. Observing both stable disease and tumor shrinkage underscores that NXP800 seems to be achieving its intended effect, even with a limited dosage.
As Ron Bentsur, Nuvectis’s Chairman and CEO, commented, “We continue to be encouraged by the early results from our Phase 1b study with NXP800. The antitumor activity observed despite patients’ advanced disease and extensive pre-treatment, while controlling for thrombocytopenia, is promising. However, it is clear that we need to increase the dose intensity to drive more efficacy in the next set of patients.”
Overcoming Challenges with Thrombocytopenia Management
A key achievement in this study has been managing thrombocytopenia, a side effect that reduces platelet counts and poses a bleeding risk. Early in the trial, patients on higher doses experienced severe (Grade 4) thrombocytopenia, raising concerns about the drug’s safety. To address this, Nuvectis adopted an intermittent dosing schedule of 50 mg daily, with a “five days on, two days off” cycle, which effectively reduced thrombocytopenia to Grade 2 in subsequent patients.
This strategic adjustment allowed Nuvectis to proceed with confidence, as managing thrombocytopenia was essential for the drug’s continued development. By adopting a dosing schedule that balances anti-tumor activity with safety, the company has demonstrated a calculated approach to maximizing NXP800’s potential.
Preparing for the Next Phase of Dose Optimization
With the success of the 50 mg intermittent dosing regimen, Nuvectis is now enrolling a new cohort to test a higher dose of 75 mg with the same dosing cycle. As Bentsur noted, “We are already enrolling patients into a cohort of up to 10-12 additional patients utilizing a regimen of 75 mg/day on an intermittent dosing schedule, which is expected to be the last cohort in this Phase 1b study.” He added that this increase in dose intensity “should provide for increased exposure that could enable us to reach our goal of demonstrating enhanced activity with acceptable overall tolerability.”
Up to twelve additional patients will be enrolled, and Nuvectis expects to report further data by the second quarter of 2025. Success with this higher dose could validate NXP800’s potential as a significant option for ARID1a-mutated ovarian cancer, offering a much-needed new therapy for patients with few alternatives.
Beyond NXP800: NXP900 in NSCLC and Beyond
While NXP800 progresses in ovarian cancer, Nuvectis is also advancing NXP900, an SRC/YES1 inhibitor with potential applications in non-small cell lung cancer (NSCLC) and other cancers. NXP900 has shown strong synergy with ALK inhibitors in NSCLC cells that have developed resistance to leading ALK inhibitors like alectinib and lorlatinib. By targeting SRC and YES1 kinases, which drive resistance mechanisms in these cancer cells, NXP900 may extend the efficacy of existing treatments and offer a new avenue for patients facing limited options.
This strategic focus on overcoming resistance mechanisms differentiates NXP900 from many other cancer therapies and aligns with a growing demand in oncology for therapies that can sustain long-term responses. With both NXP800 and NXP900, Nuvectis is positioned at the forefront of precision oncology, aiming to address some of the most challenging issues in cancer treatment.
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