PMV Pharmaceuticals, Inc. announced that a Phase 1 analysis reported promising anti-tumor activity of rezatapopt (PC14586) in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation. Rezatapopt is a first-in-class precision oncology small molecule investigational therapy that selectively targets the TP53 Y220C mutation in solid tumors. These data were featured today in a late-breaking oral presentation at the 2024 Society for Gynecologic Oncology (SGO) Annual Meeting on Women?s Cancer being held March 16-18, 2024 in San Diego, CA.

The presentation entitled, ?Phase 1 Analysis from the PYNNACLE Phase 1/2 Study PC14586 in the Subgroup of Patients with Advanced Ovarian Cancer Harboring a TP53 Y220C Mutation,? was delivered by Alison M. Schram, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center. Phase 1 data from the PYNNACLE trial (NCT04585750) demonstrated that rezatapopt has a favorable safety profile and induced responses in heavily pre-treated patients across multiple tumor types.

This subgroup analysis investigated the efficacy of rezatapopt in patients with advanced ovarian cancer treated across the efficacious dose range (1150 mg daily to 1500 mg twice daily). Patient Characteristics: As of September 5, 2023, the median age of patients with ovarian cancer (N=22) was 66 years (range 49 ? 81 years); At baseline, 20 patients had high-grade serous ovarian cancer and two had endometrioid cancer; Nineteen patients were platinum resistant and one was platinum refractory; Two patients had a BRCA2 mutation; Six patients were homologous recombination deficiency positive; All patients were KRAS wild-type and; Median number of prior lines of systemic therapy was four (range 1 ?

9). The efficacy evaluable population consisted of 15 patients with measurable disease at baseline and =1 post-baseline tumor assessment. Seven patients achieved a confirmed partial response (PR), seven had stable disease (SD), and one had progressive disease; Median duration of response was seven months; Of the 15 patients with measurable serum CA-125 at baseline, six had a CA-125 response.

Among these, five patients achieved radiographic PR and one had SD. In the overall population of 67 patients assessed in the efficacious dose range (=1150mg daily), including this subset of patients with ovarian cancer, treatment-related adverse events (TRAEs) were mostly grade 1 and 2. Most frequent TRAEs were nausea (51%), vomiting (43%), and increased blood creatinine (27%); Frequency and severity of TRAEs were similar in the ovarian cancer population compared with the overall population and; Rezatapopt administration with food led to an improvement in nausea and vomiting.