BeiGene Highlights TEVIMBRA® Data in Lung and Gastrointestinal Cancers at ESMO 2024

Rhea-AI Summary

BeiGene (NASDAQ: BGNE) announced new data for TEVIMBRA® (tislelizumab) to be presented at ESMO 2024. Key highlights include:

1. RATIONALE-315: Significant event-free survival benefit in resectable NSCLC with neoadjuvant tislelizumab plus chemotherapy.

2. RATIONALE-305: Three-year overall survival data showing long-term efficacy in first-line advanced GC/GEJC.

3. RATIONALE-307: Continued OS benefit with promising four-year OS rates in first-line squamous NSCLC.

4. Comparative effectiveness data vs. other anti-PD-1 treatments in second-line ESCC.

TEVIMBRA has been launched in Germany, Austria, and Norway following EU approvals for ESCC and NSCLC indications.

Positive

• RATIONALE-315 showed statistically significant event-free survival benefit for tislelizumab in resectable NSCLC
• Three-year overall survival data from RATIONALE-305 demonstrated long-term efficacy in first-line advanced GC/GEJC
• RATIONALE-307 showed continued OS benefit with promising four-year OS rates in first-line squamous NSCLC
• TEVIMBRA launched in Germany, Austria, and Norway following EU approvals for ESCC and NSCLC indications
• Multiple EU approvals for TEVIMBRA in various NSCLC and ESCC indications

Negative

• 72.1% of patients in the tislelizumab arm experienced grade ≥3 treatment-related adverse events in RATIONALE-315
• 15.5% of patients in the tislelizumab arm experienced serious treatment-related adverse events in RATIONALE-315

Insights

Oncology Doctor

The RATIONALE-315 study results are highly promising for resectable NSCLC patients. The 56.2% MPR and 40.7% pCR rates with neoadjuvant tislelizumab plus chemotherapy are substantially higher than placebo, indicating potential for improved outcomes. However, the increased incidence of grade ≥3 TRAEs (72.1% vs 66.4%) warrants careful patient selection and monitoring.

Long-term data from RATIONALE-305 and RATIONALE-307 demonstrate sustained efficacy in GC/GEJC and squamous NSCLC, respectively. This suggests tislelizumab's potential as a durable treatment option in these difficult-to-treat cancers. The expansion of tislelizumab's availability in Europe for ESCC and NSCLC is a significant step forward in addressing unmet needs in these aggressive malignancies.

Market Research Analyst

BeiGene's TEVIMBRA (tislelizumab) is gaining traction in the competitive immuno-oncology market. The positive data across multiple indications, including NSCLC, GC/GEJC and ESCC, position TEVIMBRA as a versatile asset in BeiGene's portfolio. The recent launches in Germany, Austria and Norway, with plans for broader European expansion, indicate strong commercial potential.

The comparative effectiveness analysis against other EU/UK-approved anti-PD-1 treatments for ESCC could be a key differentiator in a crowded market. However, BeiGene will need to navigate pricing and reimbursement challenges in different European healthcare systems to maximize TEVIMBRA's market penetration and revenue potential.

Financial Analyst

The positive clinical data and European market expansion for TEVIMBRA are significant catalysts for BeiGene (NASDAQ: BGNE). The drug's potential across multiple cancer types could drive substantial revenue growth, especially as it gains market share in Europe. However, investors should note that commercialization in new markets often requires significant investment in marketing and sales infrastructure.

BeiGene's stock may see increased interest due to TEVIMBRA's progress, but profitability will depend on successful market penetration and competitive pricing strategies. The company's ability to leverage these clinical successes into commercial wins will be important for long-term financial performance. Investors should monitor upcoming earnings reports for indications of TEVIMBRA's initial sales traction in European markets.

Results from RATIONALE-315, 307 and 305 support the benefits of PD-1 inhibitor TEVIMBRA (tislelizumab) in non-small cell lung cancer and gastric cancer/gastroesophageal junction cancer

BASEL, Switzerland--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data for TEVIMBRA^® (tislelizumab) at the European Society of Medical Oncology 2024 Congress (ESMO 2024) in Barcelona, Spain, September 13-17, 2024. BeiGene has seven abstracts accepted at ESMO 2024, with one selected for the special session revisiting the ESMO Virtual Plenary held in February 2024.

New Data Add to Evidence for TEVIMBRA Across Multiple Disease States

• As an encore to the ESMO plenary, interim results from the RATIONALE-315 study show the statistically significant event-free survival (EFS) and trend for overall survival (OS) benefit favoring neoadjuvant tislelizumab plus chemotherapy with adjuvant tislelizumab vs. placebo plus chemotherapy with adjuvant placebo for patients with resectable non-small cell lung cancer (NSCLC) (session #VP1-2024, Sept. 13 from 4:17-4:29 p.m. CEST). These results further reinforce the data presented at ESMO 2023 showing major pathologic response (MPR) and pathologic complete response (pCR) rate were significantly improved: 56.2% vs 15.0% (P<.0001) and 40.7% vs 5.7% (P<.0001), respectively. The safety profile of the tislelizumab arm was consistent with that of individual therapies, with 72.1% (vs. 66.4% in the placebo arm) of patients in the tislelizumab arm experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% (vs. 8.0% in the placebo arm) experiencing serious TRAEs. The most common TRAEs were decreased neutrophil count, decreased white blood cell count and alopecia. Improvement in symptomology from RATIONALE-315 will also be shown as patient-reported outcomes (poster #1213P, Sept. 14).
• Three-year overall survival data from RATIONALE-305 continue to demonstrate the long-term efficacy and safety of tislelizumab plus chemotherapy in patients with first-line advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) (poster #1437P, Sept. 16), as well as improvements in patient-reported outcomes (poster #1449P, Sept. 16).
• Long-term outcomes in the ITT population as well as those receiving long-term exposure to tislelizumab plus chemotherapy as treatment for first line squamous NSCLC in RATIONALE-307 show a continued OS benefit with clinically promising four-year OS rates (poster #1323P, Sept. 14).
• Relative effectiveness of tislelizumab vs. other anti-PD-1 treatments approved in the European Union and UK for second-line esophageal squamous cell carcinoma (ESCC) using anchored simulated treatment comparison of data from RATIONALE-302 and comparator clinical studies (poster #1417P, Sept. 16).

“TEVIMBRA has shown potential across multiple disease states, and the data at ESMO 2024 further supports its position as the foundational asset of our solid tumor portfolio,” said Dr. med. Jan-Henrik Terwey, Vice President, Medical Affairs Europe at BeiGene. “As part of our commitment to bring innovative cancer medicines to more patients, we recently launched TEVIMBRA in EMA-approved indications in Germany, Austria and Norway, and we are working to make TEVIMBRA available across Europe.”

TEVIMBRA in Europe

BeiGene recently launched TEVIMBRA in the first European countries following EU marketing authorizations for the treatment of eligible patients with ESCC and NSCLC. TEVIMBRA is also approved in the UK and Switzerland for eligible patients with advanced or metastatic ESCC.

“Advanced or metastatic ESCC and NSCLC are aggressive cancers with limited treatment options,” said Markus Moehler, M.D., Ph.D., of the Johannes Gutenberg University Medical Center Mainz in Germany. “The availability of tislelizumab for these patients represents an important next step to advance the treatment landscape.”

The European Commission approvals were based on the results from four randomized Phase 3 studies in the RATIONALE program: RATIONALE-302 (NCT03430843) for ESCC and RATIONALE-307 (NCT03594747), RATIONALE-304 (NCT03663205) and RATIONALE-303 (NCT03358875) for NSCLC. The approved indications for TEVIMBRA in the EU are:

• In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
• In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
• As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
• As monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.

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. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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 plans to make TEVIMBRA available across Europe; 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; BeiGene’s 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 quarterly report on Form 10-Q, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240908046480/en/

Media:

Maryline Iva

+41 61 685 2090

maryline.iva@beigene.com

Source: BeiGene, Ltd.

FAQ

What are the key findings from the RATIONALE-315 study for TEVIMBRA (BGNE) presented at ESMO 2024?

RATIONALE-315 showed statistically significant event-free survival (EFS) benefit and a trend for overall survival (OS) benefit favoring neoadjuvant tislelizumab plus chemotherapy with adjuvant tislelizumab vs. placebo plus chemotherapy in resectable non-small cell lung cancer (NSCLC).

What long-term data for TEVIMBRA (BGNE) in gastric cancer was presented at ESMO 2024?

Three-year overall survival data from RATIONALE-305 demonstrated the long-term efficacy and safety of tislelizumab plus chemotherapy in patients with first-line advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC).

In which European countries has BeiGene (BGNE) launched TEVIMBRA as of ESMO 2024?

BeiGene has launched TEVIMBRA in Germany, Austria, and Norway following EU marketing authorizations for the treatment of eligible patients with ESCC and NSCLC.

What were the safety findings for TEVIMBRA (BGNE) in the RATIONALE-315 study presented at ESMO 2024?

In RATIONALE-315, 72.1% of patients in the tislelizumab arm experienced grade ≥3 treatment-related adverse events, and 15.5% experienced serious treatment-related adverse events. The most common adverse events were decreased neutrophil count, decreased white blood cell count, and alopecia.