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Novita Pharmaceuticals Unveils Promising Results from Phase 2 NP-G2-044 Trial

On May 22, 2025, Novita Pharmaceuticals, Inc. shared compelling results from its Phase 2 clinical trial evaluating NP-G2-044, a new fascin inhibitor. The trial focused on patients with advanced and metastatic solid tumors who had previously not responded to anti-PD-1 therapies. This announcement took place during the prestigious American Society of Clinical Oncology (ASCO) Annual Meeting, underscoring the potential of NP-G2-044 as a transformative therapy for hard-to-treat cancers.

Positive Data Highlights

The presentation titled "Durable responses in ICI-refractory or acquired resistance Phase 2 study of NP-G2-044 combined with anti-PD-1 therapy" highlighted several key outcomes from the study. Novita's President and Chief Scientific Officer, Dr. Jillian Zhang, expressed optimism about the results, indicating the potential therapeutic benefits of NP-G2-044 when combined with immune checkpoint inhibitors (ICIs).

Some noteworthy findings include:

• - A Disease Control Rate of 76%, indicating significant efficacy across various tumor types.
• - An Objective Response Rate (ORR) of 21%, with three patients achieving Partial Responses and four achieving Complete Responses, including two Pathologic Complete Responses.
• - Durable responses were observed in multiple cancer types, suggesting the potential of NP-G2-044 to convert non-responsive tumors into responsive ones.
• - Among treated patients, 55% showed no new metastases.

Dr. Zhang stated, "These findings reinforce the impact of our therapy, demonstrating not just favorable response rates but also no new metastasis in a significant portion of our patient cohort. This sets a significant foundation for our upcoming Phase 3 study focusing on platinum-resistant ovarian cancer."

Study Details

The Phase 2 trial involved 45 participants, all of whom had previously progressed on anti-PD-(L)1 therapies, with a median of 2 prior treatment lines. Of note, around 20% had undergone at least 4 lines of treatment before enrolling in this trial. The combination therapy of NP-G2-044 was administered at a dose of 1600 mg daily in 4-week cycles. The primary focus of the study was the ORR, complemented by secondary endpoints including progression-free survival (PFS), outcomes related to metastasis, overall survival rates, safety, and tolerability.

Ongoing and Future Research

As Novita continues to build on these findings, an amendment to the study is being made to include additional cohorts. This will further examine the combination of NP-G2-044 with anti-PD-1 therapy across a broader spectrum of solid tumor subtypes. Additionally, analyses aimed at identifying responsive biomarkers are planned, which will assist in creating personalized treatment strategies for resistant cancers.

The next data disclosure from the Phase 2 expansion cohort is anticipated for later in 2025, with the initiation of the pivotal Phase 3 study of NP-G2-044 plus PLD (pegylated liposomal doxorubicin) in platinum-resistant ovarian cancer expected to commence in Q3 2025.

Novita's Commitment to Cancer Treatment

Novita Pharmaceuticals, a privately held company, is devoted to creating innovative therapies aimed at battling cancer. With a focus on fascin inhibition—a protein critical for cancer cell movement—Novita is tackling the challenges posed by cancer metastasis and the limitations of current immuno-oncology therapies. The promising results from NP-G2-044 provide hope for the development of effective therapies that can significantly improve treatment outcomes for patients battling advanced cancers.

For more information, you can visit Novita Pharmaceuticals.

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Cautionary Note: This article includes forward-looking statements subject to various risks and uncertainties. Reader discretion is advised regarding the potential variability of outcomes related to the discussed research and clinical trials.