1stOncology™: Cancer Intelligence Service – Page 1675 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Zai Lab Announces Acceptance of Biologics License Application for TIVDAK for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer

On March 12, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (Press release, Zai Laboratory, MAR 12, 2025, View Source [SID1234651105]).

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!

"In China, cervical cancer is a serious health concern with approximately 150,000 new cases diagnosed annually1," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Treatment options for patients experiencing recurrence or metastasis after initial treatment are limited. TIVDAK, the only antibody-drug conjugate (ADC) therapy in cervical cancer, demonstrated promising benefits including a clinically meaningful improvement in overall survival (OS) in the pivotal global innovaTV 301 trial. If approved, TIVDAK will leverage our existing commercial infrastructure for ZEJULA, expanding our ability to offer treatment for women’s cancer."

The BLA submission is supported by the results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628) and the results from the China subpopulation of this study. As reported in January 2025, the China subpopulation results were consistent with those in the global population:

TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15] in the China subpopulation who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. After a median follow-up of 11.5 months, the median OS was not reached in the TIVDAK arm versus 10.7 months in the chemotherapy arm.
Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) also favored treatment with TIVDAK.
The safety of TIVDAK in the China subpopulation was manageable and consistent with the global profile.
About TIVDAK (tisotumab vedotin-tftv)

TIVDAK (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK received full approval from U.S. Food and Drug Administration (FDA) in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Please see full U.S. prescribing information, including BOXED WARNING for TIVDAK here.

Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer in 2023, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).

About Cervical Cancer in China

Cervical cancer remains one of the leading causes of cancer death in women in China. An estimated 150,000 new cases of cervical cancer occur annually in China1. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients who currently have limited treatment options and poor outcomes.

Vivace Therapeutics Raises $35 Million in Series D Financing to Support Clinical Development of First-in-Class Cancer Drug Targeting the Hippo Pathway

On March 12, 2025 Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, reported the closing of a $35 million Series D financing (Press release, Vivace Therapeutics, MAR 12, 2025, View Source [SID1234651104]). The round was led by RA Capital Management, an existing investor, and included investment from other existing investors Canaan Partners and Cenova Capital. Proceeds will support the continued clinical development of the company’s first-in-class and best-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor, VT3989, with an initial focus on mesothelioma. In conjunction with the financing, Jake Simson, Ph.D., partner at RA Capital Management, has joined the company’s board of directors.

VT3989 is a novel small molecule cancer therapeutic that targets the Hippo pathway by inhibiting palmitoylation of members of the TEAD protein family. The compound has been evaluated in more than 150 patients to date in an ongoing, open-label Phase 1 clinical study and is the first and only member of the TEAD autopalmitoylation inhibitor class for which compelling clinical efficacy data have been publicly reported. In addition to promising efficacy, VT3989 has demonstrated excellent safety in the Phase 1 trial, positioning the compound with a best-in-class profile.

Clinical findings for VT3989 have been particularly notable in patients with mesothelioma who have failed chemotherapy and immuno-oncology combination regimens, which represent the only approved therapies in this indication. These results will be presented at a major medical conference in the second half of 2025. Based on these data, Vivace is working to advance VT3989 toward a randomized registrational Phase 3 clinical trial in patients with mesothelioma and intends to discuss its plans with the United States Food and Drug Administration (FDA) later this year.

"Since participating in Vivace’s Series C round, we have had a front row seat for the tremendous progress the company has made in its efforts to address the significant unmet treatment need of patients with mesothelioma. The team’s impressive drive and continued execution made our decision to lead this Series D round an easy one," said Dr. Simson. "Based on the clinical progress to date, we believe that VT3989 is well positioned to serve as a dramatic leap forward in the mesothelioma standard of care, offering hope to patients battling a terrible disease with limited treatment options."

"The results of our clinical evaluation of VT3989 to date give us confidence that the appropriate next step for the program is advancement into a registrational Phase 3 trial in patients with mesothelioma. We are now laser focused on executing against this strategy, including completing our ongoing clinical study and meeting with FDA to align on next steps," said Sofie Qiao, Ph.D., president and chief executive officer of Vivace Therapeutics. "We are grateful to RA Capital for leading this round, as well as the continued support from Canaan Partners and Cenova Capital. This new funding will prove critical to enabling our successful development of VT3989."

About Phase 1 study of VT3989
The Phase 1 study of VT3989 (View Source) is a multi-center, open label trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural malignant mesothelioma.

SKYLINEDX ANNOUNCES NEW STUDY DEMONSTRATING ENHANCED RISK STRATIFICATION FOR SENTINEL LYMPH NODE BIOPSY IN HEAD AND NECK MELANOMA USING THE ADVANCED MERLIN CP-GEP TEST

On March 12, 2025 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology and, inflammatory and infectious diseases, reported the publication of a groundbreaking study titled "Enhanced Risk Stratification for Sentinel Lymph Node Biopsy in Head and Neck Melanoma Using the Merlin Assay (CP-GEP) (Press release, SkylineDx, MAR 12, 2025, View Source [SID1234651103])." [1] This study, led by Ani Pazhava, MD, and colleagues from the Mayo Clinic and University Hospitals Cleveland Medical Center and SkylineDx, highlights the potential of the Merlin test to refine clinical decision-making in head and neck melanoma patients.

Sentinel lymph node biopsy (SLNB) is the gold standard for staging cutaneous melanoma. However, melanomas in the head and neck region pose unique challenges due to complex lymphatic drainage and vital anatomical structures, often leading to higher false-negative sentinel lymph node biopsy rates and higher recurrence rates compared to other locations on the body. The Merlin CP-GEP test is the only GEP test that combines clinicopathologic factors with gene expression profiling into a single algorithm to predict the risk of metastases beyond the primary melanoma. If the Merlin test result is "Low Risk" then it offers head and neck melanoma patients a non-invasive alternative for surgery as these patients may forgo SLNB due to their low risk of having nodal metastasis. Additionally, these head and neck melanoma patients that Merlin has classified as low risk for metastatic disease are less likely to experience a recurrence and have a favorable long-term survival compared to patients who have a Merlin test "High Risk" result. The study analyzed 250 patients with stage I-III head and neck melanoma diagnosed between 2004 and 2021. All of the patients in the study underwent a sentinel lymph node biopsy, which is essential for assessing the predictive power and accuracy of the Merlin test. The Merlin test classified 40.8% of patients as Low Risk for nodal metastases, predicting a corresponding 40.8% reduction in SLNB procedures, with a high negative predictive value (NPV) of 98%. This means that 98% of the patients with a Merlin test "Low Risk" result actually did have a negative sentinel lymph node biopsy. Among the SLNB-negative patients, the test identified 100 individuals as "Low Risk" with a five-year melanoma-specific survival (MSS) of 95.3%. In the subgroup T1-T2 patients, the test achieved a 56.3% SLNB reduction rate with an excellent NPV of 98.9%.

"This study underscores the transformative potential and the power of the Merlin test in accurately predicting the metastatic risk associated with complex head and neck melanomas," said Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx. "By enhancing risk stratification, we can improve patient outcomes, optimize surgical procedures and utilization of healthcare resources. This advancement represents a significant step towards personalized melanoma care."

SkylineDx is dedicated to improving patient outcomes through innovative diagnostic solutions. Our test provides actionable insights for personalized treatment strategies, enhancing the precision of healthcare worldwide.

About the Advanced CP-GEP (Merlin test)
CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced generation CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access.

Accuray to Participate at 37th Annual Roth Conference

On March 12, 2025 Accuray Incorporated (NASDAQ: ARAY) reported its participation in the 37th Annual Roth Conference taking place on March 16 -18, 2025 in Dana Point, California (Press release, Accuray, MAR 12, 2025, View Source [SID1234651102]).

Management will participate in a fireside chat on Tuesday, March 18, 2025, at 9:30am PT / 12:30pm ET, and will be available for one-on-one meetings with investors.

A live webcast of the fireside chat can be accessed here and on the Accuray website at investors.accuray.com. The webcast replay of the presentation will be available on the company’s website about one hour after the conclusion of the live presentation and will be available for 90 days.

Triumvira Immunologics to Present Updated Clinical Data at the 2025 SITC Spring Scientific, Cellular Therapy and Solid Tumors Conference

On March 12, 2025 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported it will present at the 2025 SITC (Free SITC Whitepaper) Spring Scientific, Cellular Therapy and Solid Tumors Conference in San Diego, California, from March 12-14, 2025 (Press release, Triumvira Immunologics, MAR 12, 2025, View Source [SID1234651101]). The poster presentation, titled "A Phase 1/2 Study on the Safety and Efficacy of Autologous TAC T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors," will provide a detailed overview of interim findings from the Phase 1/2 study (TACTIC-3 /NCT05862324).

The TAC technology platform, demonstrated by TAC01-CLDN18.2, reprograms T cells to harness the natural T cell receptor (TCR) signaling complex, enabling precise tumor targeting while minimizing systemic toxicity compared to conventional engineered T cell therapies.

"We are excited to share the latest clinical data from our ongoing TACTIC-3 study at the 2025 SITC (Free SITC Whitepaper) Spring Scientific Conference. These interim findings further reinforce the potential of our TAC technology to deliver safe and effective cell therapies for patients with Claudin 18.2+ advanced solid tumors," said Robert Williamson, President of Triumvira Immunologics. "At Triumvira, we remain committed to pioneering innovative T cell therapies that harness the natural biology of T cells, offering new hope to patients with limited treatment options."

Details of the abstract presentation are as follows:

Abstract Number: 28
Abstract Title: A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors
Authors: Ecaterina E. Dumbrava, Syma Iqbal, Simon Turcotte, Gregory Botta, Benjamin Schlechter, Geoffrey Ku, Peter Hosein, Sam Saibil, Miriam Gavriliuc, Maria Apostolopoulou, Mobolaji Giwa, Kara Moss, Swaminathan Murugappan, Davendra Sohal
Date: Thursday, March 13, 2025, at 4:05 pm PDT
About TACTIC-3

The TACTIC-3 trial (NCT05862324) is a first-in-human Phase 1/2 study designed to evaluate the safety, recommended Phase II dose (RP2D), pharmacokinetics, and efficacy of TAC101-CLDN18.2 in patients with Claudin 18.2+ solid tumors who have undergone 2 or more lines of prior therapy (1 prior line in patients with pancreatic tumors). The trial includes subjects with advanced gastric and other solid tumors expressing Claudin 18.2, with the potential to address significant unmet medical needs in oncology.