- Updated PC14586 Phase 1 data presented today as a late-breaking poster at 2023
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics - Confirmed responses observed in multiple tumor types including ovarian, breast, prostate, lung, and endometrial cancer with median duration of response of seven months
- Confirmed overall response rate of 38% at Recommended Phase 2 Dose of 2000 mg daily (6/16 evaluable patients) reflective of the planned Phase 2 patient population (TP53 Y220C and KRAS wild-type)
- Company to host KOL webinar at
4:00 PM ET today to review updated PC14586 Phase 1 clinical data
Study highlights include:
Patient Characteristics
- As of the
September 5, 2023 data cutoff, 67 safety evaluable patients were treated in the efficacious dose range (1150 mg daily and above). - Median age was 63 years (32-84); 61% of patients were female.
- Median number of prior lines of systemic therapy was three (range: 1-9).
Efficacy
- Confirmed responses were observed in patients whose tumors were TP53 Y220C and KRAS wild-type in the efficacious dose range, in multiple tumor types including ovarian, breast, prostate, small-cell lung, and endometrial cancer.
- Median duration of response was seven months.
- Overall response rate (ORR) per RECIST version 1.1 was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range.
Safety
- Treatment-related adverse events (TRAEs) were mostly Grade 1-2 with the most frequent TRAEs observed (>20%) being nausea, vomiting and blood creatinine increased, with a low rate of discontinuations due to a TRAE (3%).
- Gastrointestinal toxicity improved when PC14586 was administered with food.
Phase 2 Plans
- A RP2D of 2000 mg once daily was selected based on overall safety, pharmacokinetics (PK), and efficacy in alignment with the
U.S. Food and Drug Administration at an End of Phase 1 meeting held in Q3 2023. - The planned Phase 2 patient population includes TP53 Y220C and KRAS wild-type patients.
- PMV plans to initiate a registrational Phase 2 trial in early 2024.
“These updated data from our ongoing Phase 1/2 PYNNACLE clinical trial showed that PC14586, a first-in-class precision oncology investigational therapy, continues to demonstrate clinical benefit in a patient population of high unmet need. The emerging Phase 1 data have guided us in designing our Phase 2 registrational trial to enroll a TP53 Y220C and KRAS wild-type patient population. This represents approximately 90% of patients with TP53 Y220C-positive tumors and the patient population most likely to derive benefit from PC14586,” said
KOL Webinar
PMV will host a KOL webinar via webcast today at
To register for the event please click here.
Additional PMV Presentations at
The updated PYNNACLE clinical trial data will also be discussed by Dr. Alland during the Chemistry in
About the PYNNACLE Clinical Trial
The ongoing Phase 1/2 PYNNACLE study is evaluating PC14586 in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose (MTD), and Recommended Phase 2 dose (RP2D) of PC14586 when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers will also be assessed. Phase 2 will be an expansion study with the primary objective of evaluating the efficacy of PC14586 at the RP2D in patients with TP53 Y220C advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, expectations regarding timing of the Phase 2 portion of its current clinical trial for PC14586, expected therapeutic benefits of PC14586 including potential efficacy and tolerability, statements regarding the Company’s future plans or expectations for PC14586, including expectations regarding ongoing safety and response rate of participants in our clinical trials, as well as the overall success of the current and future clinical trials for PC14586, and the adequacy of the data to support its regulatory approval, and any future commercialization plans for the product candidate; and the future plans or expectations for the Company’s discovery platform for its other early-stage and clinical candidates. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities and planned clinical trials, the Company’s ability to execute on its strategy and operate as an early clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company’s ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the
Contacts
Investor Contact:
investors@pmvpharma.com
Media Contact:
kathy@greigcommunications.com
Source:
2023 GlobeNewswire, Inc., source