PMV Pharmaceuticals PYNNACLE Phase I Data of Rezatapopt in Advanced Ovarian Cancer Featured in Late-Breaking Oral Presentation at 2024 SGO Annual Meeting on Women’s Cancer - Seite 2

Deepika Jalota, Pharm.D., Chief Development Officer of PMV Pharma added, “These Phase 1 PYNNACLE data presented at the SGO meeting showed that rezatapopt, a first-in-class precision oncology investigational therapy, continues to demonstrate clinical benefit in a patient population of high unmet need. Our registrational, tumor-agnostic PYNNACLE Phase 2 trial, which includes an ovarian cancer cohort, remains on track to initiate in the first quarter of this year. The trial will assess rezatapopt as monotherapy at the recommended Phase 2 dose of 2000 mg daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors.”

Results of Phase 1 Analysis of PYNNACLE in Advanced Ovarian Cancer

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
  • Median number of prior lines of systemic therapy was four (range 1 – 9)
    

Efficacy

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
  

Safety

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
• Rezatapopt administration with food led to an improvement in nausea and vomiting