PMV Pharma has announced encouraging interim results from the phase 2 portion of its PYNNACLE trial, evaluating rezatapopt monotherapy in patients with advanced solid tumours harbouring a TP53 Y220C mutation.

Confirmed responses were observed across eight tumour types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gall bladder and ampullary carcinoma. Among 97 evaluable patients, the overall response rate (ORR) was 33%, with a median duration of response of 6.2 months.

The ovarian cancer cohort showed the strongest efficacy, with a 43% ORR among 44 patients. This included one complete response and 17 confirmed partial responses. Median duration of response was 7.6 months.

Endometrial cancer patients showed a 60% ORR, while lung cancer and breast cancer cohorts reported 22% and 18% respectively. Other solid tumours demonstrated a 21% ORR.

Safety data from 109 patients indicated that most treatment-related adverse events were Grade 1-2. Grade 3 events occurred in fewer than 6% of cases and resolved on treatment. No discontinuations were reported due to liver enzyme elevations.

Rezatapopt was better tolerated when administered with food, improving gastrointestinal outcomes compared to phase 1 data. Lab abnormalities were mostly transient and reversible, with a 3.7% discontinuation rate due to adverse events.

Bluejay Therapeutics has enrolled the first patient in AZURE-2, a global phase 3 clinical trial evaluating brelovitug (BJT-778) as a monotherapy for chronic hepatitis D (CHD). The study compares brelovitug with Hepcludex (bulevirtide) in adults with CHD.

AZURE-2 is a randomised, controlled trial assessing weekly self-administered subcutaneous injections of brelovitug. The primary endpoint is a composite response at week 48, defined as undetectable hepatitis D virus RNA and normalised alanine aminotransferase (ALT) levels.

ALT is a key marker of liver inflammation, which contributes to cirrhosis and liver cancer. The trial forms part of Bluejay’s global registrational programme for brelovitug.

Nancy Shulman, Chief Medical Officer of Bluejay Therapeutics, said: “Chronic hepatitis D is the most severe form of viral hepatitis, yet it remains underserved, with limited or no approved treatment options in most countries.”

Keting Chu, Founder and Chief Executive Officer of Bluejay Therapeutics, said: “Bluejay continues to swiftly advance our registrational programme for brelovitug in CHD. We are proud to support the patients and providers in need of new hope.”

AZURE-1, a separate phase 3 trial comparing brelovitug with delayed treatment, began in March 2025 and is enrolling patients in the US and globally.