BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Rhea-AI Summary

BeiGene, Ltd. announces FDA acceptance of BLA for TEVIMBRA in combination with chemotherapy for advanced gastric/GEJ cancer treatment. Results from RATIONALE-305 trial show significant overall survival improvement. FDA action date set for December 2024.

Oncology Doctor

The acceptance of the Biologics License Application (BLA) by the FDA for TEVIMBRA in treating advanced gastric or G/GEJ adenocarcinoma represents a significant milestone in the field of oncology. The clinical data indicating a 20% reduction in the risk of death and improvements in overall survival, objective response rate and median duration of response underscores the potential of TEVIMBRA as a valuable treatment option. This is particularly relevant given the poor prognosis typically associated with these advanced cancers and the limited number of effective treatments currently available.

From a medical standpoint, the manageable safety profile aligning with known effects of anti-PD-1 antibodies is also noteworthy, as it suggests a tolerable treatment for patients that could be integrated into existing therapeutic regimens. The higher incidence of Grade ≥3 treatment-related adverse events (TRAEs) in the TEVIMBRA plus chemotherapy arm, however, warrants close monitoring and management in clinical practice to ensure patient safety and treatment adherence.

Market Research Analyst

The FDA's acceptance of TEVIMBRA's BLA could potentially impact BeiGene's market position, particularly in the oncology sector. With over 900,000 patients globally having been prescribed TEVIMBRA, its approval for additional indications such as advanced gastric/GEJ cancer could expand the drug's market reach and increase its revenue potential. The positive trial outcomes, along with the drug's approval by the European Commission for ESCC, signal strong commercial prospects, especially considering the high unmet need in these cancer subtypes.

Investors may view this development as a positive indicator of BeiGene's pipeline strength and its ability to deliver on key regulatory milestones. The company's extensive trial program for TEVIMBRA, including over 17 potentially registration-enabling trials, further positions it as a leader in the PD-(L)1 inhibitor space, which is a rapidly growing segment in cancer therapeutics.

Financial Analyst

BeiGene's announcement is likely to be closely watched by investors, as FDA acceptance of a BLA often precedes potential market expansion and revenue growth. The set Prescription Drug User Fee Act (PDUFA) target action date in December 2024 provides a clear timeline for market analysts to anticipate potential stock movements and financial outcomes. The demonstrated efficacy of TEVIMBRA in the RATIONALE-305 trial, combined with a manageable safety profile, could lead to a favorable FDA decision, thereby enhancing investor confidence in BeiGene's future performance.

It is important to consider the competitive landscape and pricing pressures within the oncology market, as these factors will influence the financial impact of TEVIMBRA's potential approval. Additionally, the ongoing reviews for other indications of TEVIMBRA by the FDA could compound the financial implications for BeiGene, contingent on the outcomes of these reviews.

Application based on results from global Phase 3 RATIONALE-305 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival in advanced gastric/GEJ cancer

Prescription Drug User Fee Act target action date set for December 2024

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for TEVIMBRA^® (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The FDA’s action date on the BLA is expected in December 2024.

“There is an urgent need for new treatment options for gastric cancer, which is often diagnosed at the advanced or metastatic stage,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer. This FDA acceptance brings us one step closer to delivering on a new treatment option for patients who often face poor prognoses.”

The filing is based on results from the global RATIONALE-305 trial. The study met its primary endpoint of overall survival of 15.0 months for patients treated with TEVIMBRA in combination with investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), demonstrating a 20% reduction in the risk of death. Additionally, TEVIMBRA plus chemotherapy was associated with a higher objective response rate (47.3% vs. 40.5%) and median duration of response (8.6 months vs. 7.2 months) compared to placebo plus chemotherapy. Median progression-free survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]). The safety profile for TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.

Grade ≥3 treatment-related adverse events (TRAEs) occurred in 53.8% of patients in the TEVIMBRA plus chemotherapy arm and 49.8% of patients in the placebo plus chemotherapy arm. The most common TRAEs of any grade with an incidence ≥30% were nausea, decreased appetite, platelet count decreased, neutrophil count decreased, vomiting, and anaemia.

TEVIMBRA was recently approved by the European Commission for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy. The FDA is also reviewing a BLA for TEVIMBRA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC with a target action date in July 2024. A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.

BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and 4 Phase 2 trials have already had positive readouts. Through these trials, TEVIMBRA has demonstrated its ability to safely deliver clinically meaningful improvements in survival benefits and quality of life for hundreds of thousands of cancer patients across a range of tumor types – in many cases, regardless of PD-(L)1 status – both as monotherapy and in combination with other regimens. More than 900,000 patients have been prescribed TEVIMBRA globally to date.

About RATIONALE-305
RATIONALE-305 (NCT03777657) is a randomized, double-blind, placebo-controlled, global Phase 3 that enrolled 997 patients with advanced unresectable or metastatic G/GEJ adenocarcinoma. The primary endpoint was OS, with prespecified hierarchy testing for the PD-L1 high population followed by the intent-to-treat (ITT) population. Results of the final analysis of the ITT population were presented as a late-breaking oral presentation during the European Society for Medical Oncology (ESMO) Congress 2023.

About Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth highest leading cause of cancer mortality.¹ Nearly 1 million new patients were diagnosed with gastric cancer in 2022, and 660,000 deaths were reported globally. In the U.S., it is estimated there were approximately 27,000 patients diagnosed with gastric cancer and 11,000 deaths from the disease in 2024.² The five-year survival rate for gastric cancer in the U.S. is 36%.³ Gastroesophageal junction adenocarcinoma occurs at the area where the esophagus joins the stomach, which is just beneath the diaphragm (the thin sheet of breathing muscle under the lungs).⁴

About TEVIMBRA^® (tislelizumab)
Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

About BeiGene
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding TEVIMBRA’s potential to improve survival for patients with gastric and gastroesophageal junction cancer; the ability of TEVIMBRA to be a treatment option for patients with poor prognoses; future regulatory approval of TEVIMBRA; TEVIMBRA’s ability to safely delivery clinically meaningful improvements in survival benefits and quality of life to cancer patients; BeiGene’s advancement, anticipated clinical development, regulatory submissions and commercialization of TEVIMBRA; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

To access BeiGene media resources, please visit our News & Media site.

¹ Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today. Accessed February 9, 2024.
² American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024.
³ National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: stomach cancer. Available at https://seer.cancer.gov/statfacts/html/stomach.html. Accessed January 22, 2024.
⁴ American Cancer Society. What Is Stomach Cancer? https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240227824706/en/

Investor:

Liza Heapes

+1 857-302-5663

ir@beigene.com

Media:

Kyle Blankenship

+1 667-351-5176

media@beigene.com

Source: BeiGene, Ltd.

FAQ

What is the FDA action date for the BLA of TEVIMBRA?

The FDA action date for the Biologics License Application (BLA) of TEVIMBRA is set for December 2024.

What is the primary endpoint met in the RATIONALE-305 trial for TEVIMBRA?

The primary endpoint of overall survival was met in the RATIONALE-305 trial, showing a 20% reduction in the risk of death for patients treated with TEVIMBRA.

What is the objective response rate for TEVIMBRA plus chemotherapy compared to placebo in the trial?

TEVIMBRA plus chemotherapy showed a higher objective response rate of 47.3% compared to 40.5% for placebo in the RATIONALE-305 trial.

What is the safety profile of TEVIMBRA in combination with chemotherapy?

The safety profile of TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies, with common adverse events like nausea and decreased appetite.

How many potentially registration-enabling trials have been launched with TEVIMBRA by BeiGene?

BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, demonstrating its ability to deliver survival benefits for cancer patients.