Therapy Areas: Oncology
Novita Pharmaceuticals reveals additional results from Phase 2 trial in patients with advanced and metastatic solid tumours
26 February 2025 -

Clinical-stage pharmaceutical company Novita Pharmaceuticals Inc on Tuesday reported additional results from its Phase 2 study assessing NP-G2-044 in combination with SOC anti-PD-1 therapy in patients with advanced solid tumours resistant to prior anti-PD-1 therapy.

The data was revealed in a poster presentation at the American Association for Cancer Research Immuno-oncology (AACR IO) Annual Meeting.

Findings from the study indicate that NP-G2-044 provides a novel therapeutic opportunity when combined with immune checkpoint inhibitors (ICIs).

Among the 45 patients treated with NP-G2-044 as of the last data cutoff (October 2024), 80% had progressed on prior anti-PD-(L)1 therapies. The anti-PD-1 Combination RP2D for NP-G2-044 was 1600 mg QD with 4-week cycles. The primary endpoint was objective response rate (ORR), and secondary endpoints included progression-free survival, metastasis-free interval, overall survival, safety and tolerability.

Results showed a disease control rate of 76% and an ORR of 21%, including four patients with partial response and three patients with complete responses including pathologic complete response.

A significant proportion of patients experienced durable responses and tumour control across at least seven cancer types, including cases converted from ICI-non-responsive to ICI-responsive.

Long lasting objective responses were observed, and notable outcomes included a complete response in a cervical cancer patient, target lesion complete response in an endometrial cancer patient, pathological complete responses in a pancreatic cancer patient and a patient with gastroesophageal junction adenocarcinoma and partial responses in cutaneous squamous cell carcinoma, non-small cell lung cancer and cholangiocarcinoma.

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