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]).

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"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.

On March 12, 2025 Faeth Therapeutics (Faeth), a clinical-stage biotechnology company focused on metabolism, and The GOG Foundation, Inc. (GOG-F), a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies, reported the first patient has been dosed in its Phase 2 combination trial of PIKTOR, which is FTH-001 (serabelisib) and FTH-003 (sapanisertib) with paclitaxel (Press release, Faeth Therapeutics, MAR 12, 2025, View Source [SID1234651106]). The trial is the most advanced of its kind to investigate a novel approach of dual PI3Kɑ-mTORC1/2 inhibition targeting cancer metabolism in patients with endometrial cancer.

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The PI3K/AKT/mTOR pathway is the most frequently mutated pathway in cancer and is essential for tumor metabolism. Endometrial cancer has the highest frequency of PI3K pathway mutations of any solid tumor, yet there are no approved therapies addressing this need. FTH-001, a PI3Kɑ inhibitor, and FTH-003, an mTORC 1/2 inhibitor, have both demonstrated potential in multiple previous cancer clinical trials and their combination represents a unique "multi-node" approach to targeting this pathway.

The current study, An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus Diet, in Patients With Advanced or Recurrent Endometrial Cancer (FTH-PIK-201, GOG-3111)2 will expand on the strong Phase 1b data1 showing an 80% ORR in patients with endometrioid endometrial cancer with 11 months of progression-free survival. The Phase 2 study is based on Faeth’s metabolism-focused platform for developing novel therapeutic approaches. Endometrial cancer is one of the leading causes of cancer death in women and there is a high unmet need in patients with advanced and relapsed disease who have progressed after first line carboplatin-based therapy.

"Thanks to Faeth’s ability to uncover novel metabolism-targeting strategies, we are positioned to leverage the PIKTOR approach for endometrial cancer and other solid tumors," said Anand Parikh, J.D., Chief Executive Officer of Faeth Therapeutics. "Over its five decades, the GOG Foundation has established itself as a leading clinical partner against gynecologic cancers, and we are confident they will help us pave the way for the next generation of cancer treatments."

"This unique approach to target cancer metabolism has demonstrated impressive early results. We look forward to this trial to hopefully confirm these early findings and perhaps transform the way we treat patients with endometrial cancer," said David Starks, MD, Principal Investigator and Associate Professor, Avera Cancer Institute and University of South Dakota Sanford School of Medicine.

"Endometrial cancer is the leading cause of deaths among all gynecologic cancers. Finding better treatment options remains our highest priority. We are excited to partner with Faeth Therapeutics to further investigate this novel therapeutic approach," said Brian Slomovitz, MD, Director, Gynecologic Oncology, Mount Sinai Medical Center and Uterine Cancer Trial Lead, GOG Partners.

On March 12, 2025 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report, reported that its phase 1 clinical trial has demonstrated the safety and early efficacy of targeted chemotherapy using PIPAC combined with systemic chemotherapy for patients with colorectal and appendiceal cancer that has spread to the peritoneum of the abdominal cavity (Press release, City of Hope, MAR 12, 2025, View Source [SID1234651107]). This data will be presented at a March 18 press briefing spotlighting some of the most consequential research to be shared at this year’s Society of Surgical Oncology Annual Meeting (SSO).

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Of all the possible sites that cancer can spread to, the abdomen’s peritoneum is the worst when it comes to survival rates because it is difficult for systemic chemotherapy to reach this region due to a low number of blood vessels. When surgery is not an option and peritoneal metastases are left untreated, these patients survive only a few months and few make it past one year with standard treatment.

"Up until recently, delivering a uniform dose of chemotherapy in the abdomen has not been possible. At City of Hope, we have been evaluating the use of pressurized intraperitoneal aerosolized chemotherapy, or PIPAC, which is the most optimized way to deliver chemotherapy in the abdominal cavity. It increases targeted medicinal exposure while limiting toxicity," said Mustafa Raoof, M.D., M.S., assistant professor in City of Hope’s Division of Surgical Oncology and first author of the SSO abstract entitled "Dose escalation Phase 1 trial of Mitomycin C Pressurized Intraperitoneal Aerosolized Chemotherapy in Combination with Systemic Chemotherapy for Unresectable Appendiceal and Colorectal Carcinomatosis," which will be featured in the SSO press briefing at 9 a.m. PST on March 18.

The Society of Surgical Oncology is an international community of cancer surgeons and care professionals who are shaping advances in the delivery of the highest quality surgical care for cancer patients. City of Hope was the first U.S. institution to offer PIPAC in a clinical trial, and has hosted the first and second U.S. PIPAC training workshops.

The City of Hope-led multicenter phase 1 trial, in collaboration with Northwell Health and Mayo Clinic in Florida, included 19 patients with a median age of 60 who had colorectal or appendiceal cancer that had spread to the peritoneum and was inoperable even after four months of first- or second-line systemic chemotherapy. These patients received treatments that included Mitomycin C chemotherapy targeted to the abdomen via PIPAC and standard-of-care FOLFIRI systemic chemotherapy. This combination treatment is necessary to maximize the medicinal delivery via systemic and regional exposure.

"While we were able to demonstrate safety in this study, what we are really excited about is the early efficacy results seen as measured by several response criteria — histologic, laparoscopic, radiographic and tumor marker CEA," Dr. Raoof said. "This trial provides strong rationale for a multicenter randomized trial, which City of Hope will open soon. The new trial will determine if the addition of PIPAC to standard therapy could both improve survival and preserve quality of life. At this time, we caution against off-label use of PIPAC until the definitive efficacy of PIPAC in this population is proven."

In addition to Dr. Raoof’s oral abstract to be presented March 28 at 8:26 p.m. ET in TCC Ballroom BC, City of Hope also will have five poster abstracts at SSO 2025 happening March 27 to 29 in Tampa, Florida:

P64: Genetic Pathogenic Variants in Asian American/Pacific Islander Women with Breast Cancer: Implications for Surgical and Oncologic Care
Presenter: Jennifer Tseng, M.D.
P167: Impact of Systematic Discontinuation of Mitomycin C HIPEC for Colorectal Peritoneal Metastasis on Oncologic Outcomes at an NCI Cancer Center
Presenter: Muhammad Talha Waheed, M.D.
P187: Upfront Colectomy vs. Initial Appendectomy followed by Completion Colectomy for Appendiceal Cancer: Comparison of Outcomes
Presenter: Muhammad Talha Waheed, M.D.
P453: Percutaneous Transesophageal Gastrostomy as an Alternative Approach for Palliative Decompression of Malignant Bowel Obstruction
Presenter: Kristofor Olson, M.D., Ph.D.
P114: Reduced hepatotoxicity and equivalent survival with a lower hepatic arterial floxuridine starting dose in the adjuvant treatment of colorectal cancer liver metastases
Presenter: Kevin Labadie, M.D.

On March 12, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported it will participate at the 37th Annual Roth Conference on March 16th to 18th (Press release, Actinium Pharmaceuticals, MAR 12, 2025, View Source [SID1234651092]).

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Actinium management will be in attendance during the conference and will be available for 1-on-1 meetings on March 17th and 18th. Interested investors should contact their ROTH representative or submit a registration request at Roth2025Registration.

On March 11, 2025 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will participate at the Stifel 2025 Virtual CNS Forum at 1:30 p.m. Eastern Time on Tuesday, March 18, 2025 (Press release, Neurocrine Biosciences, MAR 11, 2025, View Source [SID1234651071]). Chief Executive Officer Kyle Gano and Chief Medical Officer Eiry Roberts will present at the conference.

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The live webcast can be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.