On May 22, 2025 Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, reported additional results from its Phase 2 study (NCT05023486) evaluating NP-G2-044 in combination with SOC anti-PD-1 therapy in patients with advanced solid tumors resistant to prior anti-PD-1 therapy at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Novita Pharmaceuticals, MAY 22, 2025, View Source [SID1234653337]). The oral presentation, titled "Durable responses in ICI-refractory or acquired resistance: Phase 2 study of NP-G2-044 combined with anti-PD-1 therapy", further supports the potential therapeutic benefit of NP-G2-044 in combination with immune checkpoint inhibitors (ICIs) to block metastasis and enhance immune response.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by the continued positive data from our Phase 2 trial of NP=G2-044, which highlight the therapeutic opportunity of our first-in-class fascin inhibitor for patients with advanced and metastatic solid tumors," said Jillian Zhang, Ph.D., President & Chief Scientific Officer of Novita. "Continued safety and durable efficacy findings across multiple tumor types speak to the impact of our novel therapy, as we see favorable response rates and no new metastases from more than half of patients. These data set the foundation for our Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer, which we plan to start enrolling later this year."

Among the 45 patients treated with NP-G2-044 as of the most recent data cutoff (April 23, 2025), all had progressed on prior anti-PD-(L)1 therapies, with a median number of 2 prior lines, and with 20% of patients having at least 4 prior lines. 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 (PFS), metastasis-free interval (MFI), overall survival (OS), safety, and tolerability.

Key highlights include:

A Disease Control Rate of 76% (includes patients with Stable Disease and Objective Responses).
An ORR of 21% including three patients with Partial Response (PR) and four patients with Complete Responses (CR) including two Pathologic Complete Responses.
Results indicate durable responses and tumor control in a significant proportion of patients across at least seven cancer types, including cases converted from ICI-non-responsive to ICI-responsive.
Long lasting objective responses have been observed across multiple tumor types, with four patients in ongoing treatment, two of which show duration lasting more than 80 weeks in pancreatic cancer and endometrial cancer.
55% of all patients show no new metastases.
Notable outcomes include continued CR in a cervical cancer patient, target lesion CR in an endometrial cancer patient, pathological CRs in a pancreatic cancer patient and a patient with gastroesophageal junction adenocarcinoma, clinical CR in a cutaneous squamous cell carcinoma patient, and PRs in non-small cell lung cancer and cholangiocarcinoma.
Increased T-cell infiltration and enhanced proliferation as well as expanded activated dendritic cells (DCs) in the tumor microenvironment were observed, supporting the therapeutic function of fascin inhibition and immune activation.
An amendment to the study is currently underway to open additional cohorts, which will aim to further evaluate the combination of NP-G2-044 with anti-PD-1 therapy across patient populations and solid tumor subtypes. Future analysis will also explore biomarkers for response prediction and mechanisms of resistance, guiding personalized approaches in treatment-resistant cancer. Novita plans to share additional data from the Phase 2 expansion cohort of NP-G2-044 in combination with ICI in the second half of 2025 with enrollment in its pivotal Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer expected to begin in the third quarter of 2025.