Nuvation Bio has announced it will be pausing the development of its NUV-868 oncology drug following safety and efficacy analysis from a Phase I trial of the candidate in solid tumours.
The company completed an internal analysis of efficacy and safety data collected from the Phase I monotherapy and Phase Ib combination studies of NUV-868 and has currently decided against moving ahead to Phase II.
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The company said that Phase II would have evaluated NUV-868 as a monotherapy or in combination with olaparib or enzalutamide in the advanced solid tumour indications, which were included in the Phase I and Ib trials.
“This decision comes after careful review of the data generated in the Phase I monotherapy study and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide,” said Dr David Hung, founder, and CEO of Nuvation Bio.
“We are exploring the next steps for NUV-868 in new indications and will share updates as available.”
Nuvation is considering further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.
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By GlobalDataThe Phase I/II trial (NCT05252390), which includes the Phase Ib investigations, lists an estimated patient enrolment of 657 with a study completion date in November 2026, according to ClinicalTrials.gov.
The Phase I portion of the trial was a dose-escalating trial, administering NUV-868 at escalating dose levels until the maximum tolerated dose (MTD) is reached or a recommended Phase II dose (RP2D) is determined.
The Phase Ib dose-escalation study evaluated NUV-868 in combination with AstraZeneca’s Lynparza (Olaparib) for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer, and other solid tumours, and in combination with Pfizer and Astellas’ Xtandi (enzalutamide) for the treatment of patients with mCRPC.
Nuvation Bio also plans to unveil data from a Phase II global study, TRUST-II of its lead candidate taletrectinib at the World Conference on Lung Cancer 2024 (WCLC) in San Diego between 7 and 10 September.
The company will present further data at the European Society for Medical Oncology 2024 (ESMO) meeting taking place in Barcelona, Spain, from 13 to 17 September, including pooled efficacy and safety data from both pivotal TRUST-I and TRUST-II studies.
The company shared data from the TRUST-I study, which was conducted in China, at the American Society of Clinical Oncology (ASCO) conference in Chicago, which demonstrated taletrectinib’s efficacy, durability, and safety profiles, despite an early cut-off.
All data will be used to support an NDA filing to the US Food and Drug Administration with the company hoping to commercialise taletrectinib in 2025.
Nuvation Bio acquired taletrectinib as part of a full acquisition of AnHeart Therapeutics, which took place in March 2024.
The company also has other pipeline candidates which are in trials, including NUV-1511 and safusidenib.
