Everest Medicines Announces That Licensing Partner Immunomedics has Received FDA Accelerated Approval for Trodelvy (sacituzumab govitecan-hziy) in Previously-treated Metastatic Triple-Negative Breast Cancer

April 24, 2020

Trodelvy is the first FDA-approved antibody-drug conjugate (ADC) that targets Trop-2 antigen, specifically for the treatment of metastatic triple-negative breast cancer

SHANGHAI, China, April 24, 2020 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by Immunomedics, Inc. (NASDAQ:IMMU) for sacituzumab govitecan-hziy (marketed as Trodelvy in the US) for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. The approval came almost one and half months ahead of its U.S. Prescription Drug User Fee Act (PDUFA) date of June 2, 2020.

In April 2019, Everest Medicines entered into an exclusive license agreement to develop, register, and commercialize Trodelvy in Greater China, South Korea and certain Southeast Asian countries and territories. On April 22, 2020, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of People’s Republic of China approved the Clinical Trial Application (CTA) of Trodelvy, which will allow Everest Medicines to initiate a pivotal Phase 3 clinical trial of this investigational therapy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease in China. The Company plans to initiate this trial in the first half of 2020.

The FDA previously granted Breakthrough Therapy Designation and Priority Review to Trodelvy, which was approved under the Accelerated Approval Program based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter, Phase 2 study conducted in 108 patients. Immunomedics’ confirmatory Phase 3 ASCENT study was recently halted by the independent Data Safety Monitoring Committee for “compelling evidence of clinical benefit across multiple endpoints.”

“Trodelvy is the first ADC approved therapy for metastatic TNBC worldwide. mTNBC is a highly aggressive cancer with limited existing therapeutic options and an overall survival rate that has remain unchanged for two decades. This important approval provides clinicians with a novel treatment option for treating patients with this devastating disease,” stated Prof. Binghe Xu, MD, PhD, Chief of f National Clinical Research Center for Anti-Cancer Drugs and Principle Investigator of Trodelvy China Registration Study. “As clinicians, we look forward to the initiation of a clinical trial in China to help advance this important drug for Chinese patients as quickly as possible.”

“We are excited to continue our efforts to potentially bring Trodelvy to greater China and other select Asian countries and territories. The US approval of Trodelvy validates and has the potential to accelerate Everest’s clinical development in China and Asia. We are committed to broadening the potential use of this important new medicine across other oncology indications in collaboration with our partner, Immunomedics, as we continue to focus our work to address disease areas with high unmet need in the Asia region,” said Yang Shi, MD, Chief Medical Officer for Oncology and Immunology at Everest Medicines.

“As the incidence of triple-negative breast cancer continues to rise in China, many patients are left with no therapeutic options after second-line chemotherapy treatments. These patients are in urgent need of a breakthrough therapy with the potential to extend their lives. I am very excited to learn that Trodelvy has been approved by the FDA and look forward to the possibility of making this medicine available to benefit breast cancer patients in China,” said Ms. Anli Shi, President of Beijing Love Book Cancer Foundation and President of Cancer Rehabilitation Society of CACA (CRS).

“The approval of Trodelvy by the US FDA is great news for patients with mTNBC and further validation of the Everest Medicines model to in-license global innovation for development in China and Asia. With our recent CTA approval in China we are working to quickly bring this medicine to Chinese patients who suffer with mTNBC as our development team doubles-down on their efforts to accelerate clinical development in China,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

About TRODELVY (sacituzumab govitecan-hziy)

Trodelvy (sacituzumab govitecan-hziy) is an antibody–drug conjugate (ADC) that links SN-38, the active metabolite of irinotecan, via a hydrolyzable linker to a humanized monoclonal antibody against the human trophoblast cell-surface antigen 2 (Trop-2). Trop-2 is a membrane antigen that is frequently over-expressed in many common epithelial cancers. Trodelvy delivers high concentrations of the SN-38 payload to tumors. Trodelvy has been approved by US FDA for the treatment in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

About Triple-Negative Breast Cancer (TNBC)

TNBC is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide.i-iii The median age of breast cancer diagnoses tends to be younger in China than western countries, and the percentage of TNBC molecular subtype has increased to 20.3% in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.iv-viii

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. For more information, please visit its website at www.everestmedicines.com.

For further information, please contact:

Media in US and Europe:
Darcie Robinson
Vice President
Westwicke PR
(203) 919-7905
darcie.robinson@icrinc.com

Media in China:
Edmond Lococo
Senior Vice President
ICR Asia
+86 (10) 6583-7510
edmond.lococo@icrinc.com

Jianfeng Pei
Vice President
ICR Asia
+86 139 1182 4874
jianfeng.pei@icrinc.com

References

i. DeSantis CE, Fedewa SA, Goding Sauer A, Kramer JL, Smith RA, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin 2016;66:31-42.
ii. 4. Plasilova ML, Hayse B, Killelea BK, Horowitz NR, Chagpar AB, Lannin DR. Features of triple-negative breast cancer: analysis of 38,813 cases from the National Cancer Database. Medicine (Baltimore) 2016;95(35):e4614.
iii. Kohler BA, Sherman RL, Howlader N, et al. Annual report to the nation on the status of cancer, 1975-2011, featuring incidence of breast cancer subtypes by race/ ethnicity, poverty, and state. J Natl Cancer Inst 2015;107(6):djv048.
iv. Khosravi-Shahi P, Cabezón-Gutiérrez L, Custodio-Cabello S. Metastatic triple negative breast cancer: optimizing treatment options, new and emerging targeted therapies. Asia Pac J Clin Oncol 2018;14: 32-9.
v. Brufsky A, Valero V, Tiangco B, et al. Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial. Breast Cancer Res Treat 2012;133: 1067-75.
vi. Perez EA, Patel T, Moreno-Aspitia A. Efficacy of ixabepilone in ER/PR/HER2- negative (triple-negative) breast cancer. Breast Cancer Res Treat 2010;121:261-71.
vii. Park IH, Im SA, Jung KH, et al. Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: PROCEED trial (KCSG BR 11-01). Cancer Res Treat 2019; 51:43-52.
viii. Twelves C, Awada A, Cortes J, et al. Subgroup analyses from a phase 3, openlabel, randomized study of eribulin mesylate versus capecitabine in pretreated patients with advanced or metastatic breast cancer. Breast Cancer (Auckl) 2016;10:77- 84

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