On September 10, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported that it will present new data on TEVIMBRA (tislelizumab) at the European Society for Medical Oncology 2024 Congress (ESMO 2024) in Barcelona, ​​Spain, September 13-17, 2024 (Press release, BeiGene, SEP 10, 2024, View Source [SID1234646494]). Seven BeiGene abstracts have been selected for the ESMO (Free ESMO Whitepaper) 2024 Congress, including one that has been selected for the special session revisiting the virtual ESMO (Free ESMO Whitepaper) plenary held in February 2024.

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New data strengthen evidence for TEVIMBRA’s efficacy in multiple conditions

As a reminder of the ESMO (Free ESMO Whitepaper) plenary session, interim results from the RATIONALE-315 study show a statistically significant benefit in terms of event-free survival (EFS) and overall survival (OS) trend supporting neoadjuvant tislelizumab plus chemotherapy with adjuvant tislelizumab compared with placebo plus chemotherapy with adjuvant placebo for patients with resectable non-small cell lung cancer (NSCLC) (session #VP1-2024, 13 September from 16:17 to 16:29 CEST). These results confirm data presented at ESMO (Free ESMO Whitepaper) 2023, showing that the major pathological response (MPR) and pathological complete response (pCR) rates were significantly improved: 56.2% vs. 15.0% (P<0.0001) and 40.7% vs. 5.7% (P<0.0001), respectively. The safety profile of the tislelizumab arm was consistent with that of the 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 treatment-related adverse events were neutrophil count decreased, white blood cell count decreased, and alopecia. Symptom improvement achieved with RATIONALE-315 will also be presented as patient-reported outcomes (Poster #1213P, September 14).
Three-year overall survival data from the RATIONALE-305 study continue to demonstrate the long-term efficacy and safety of tislelizumab in combination with chemotherapy in patients with first-line advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) (Poster #1437P, September 16), as well as improved patient-reported outcomes (Poster #1449P, September 16).
Long-term results from the RATIONALE-307 study in the ITT population as well as in the population with long-term exposure to tislelizumab plus chemotherapy for the first-line treatment of squamous cell NSCLC show a continued OS benefit, with clinically promising four-year OS rates (Poster No. 1323P, September 14).
Relative efficacy of tislelizumab compared with other anti-PD-1 therapies approved in the European Union and the United Kingdom for the second-line treatment of esophageal squamous cell carcinoma (ESC) using a grounded theory simulated treatment comparison of data from the RATIONALE-302 study and comparative clinical studies (poster #1417P, September 16).
"TEVIMBRA has demonstrated potential in multiple disease states, and the data presented at ESMO (Free ESMO Whitepaper) 2024 reinforce its position as a cornerstone asset in our solid tumor pipeline," said Dr. Jan-Henrik Terwey, Vice President, Medical Affairs, Europe, 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 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 EOC and NSCLC. TEVIMBRA is also approved in the United Kingdom and Switzerland for eligible patients with advanced or metastatic EOC.

"Advanced or metastatic EOC and NSCLC are aggressive cancers with limited treatment options," said Markus Moehler, MD, PhD, of Johannes Gutenberg University Medical Center Mainz in Germany. "The availability of tislelizumab for these patients represents an important next step in changing the treatment landscape."

The European Commission’s authorisations are based on the results of four randomised phase 3 studies in the RATIONALE programme: RATIONALE-302 ( NCT03430843 ) in EOC and RATIONALE-307 ( NCT03594747 ), RATIONALE-304 ( NCT03663205 ) and RATIONALE-303 ( NCT03358875 ) in NSCLC. The approved indications for TEVIMBRA in the EU are:

In combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with locally advanced squamous cell NSCLC who 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, without positive EGFR or ALK 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 mutation-positive or ALK-positive NSCLC should also have received targeted therapies prior to receiving tislelizumab.
As monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic EOC after prior platinum-based chemotherapy.
About TEVIMBRA (tislelizumab)

Tislelizumab is a uniquely designed humanized anti-programmed death protein 1 (PD-1) immunoglobulin G4 (IgG4) monoclonal antibody with high affinity and specificity of binding against PD-1. It is designed to reduce binding to Fc-gamma (Fcγ) receptors on macrophages, which helps the body’s immune cells detect and fight tumors.