Anti-PD-1 antibody gains EU approval for oesophageal cancer

The European Commission (EC) has approved TEVIMBRA^® (tislelizumab) as monotherapy for adults with oesophageal cancer.

The humanised IgG4 anti-PD-1 antibody is indicated for unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy.

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The FDA’s target action date is the second half of 2024.

Regaining global rights for tislelizumab

Additionally, BeiGene has regained global rights to develop, manufacture, and commercialise TEVIMBRA (tislelizumab), following an agreement with Novartis.

“We are excited to regain the global rights to TEVIMBRA, which enables us to build out our in-house solid tumour commercial capabilities… we plan to rapidly accelerate our regulatory and development plans across a wider range of tumour types,” commented John Oyler, Co-Founder, Chairman and CEO of BeiGene. “BeiGene will continue to work with Novartis on development, regulatory and manufacturing priorities. Novartis will manufacture TEVIMBRA for many markets worldwide and explore its potential in combination with their oncology assets.”

Under its original agreement with BeiGene, Novartis was responsible for regulatory submissions and had the right to commercialise tislelizumab in licensed countries following regulatory approval.

The treatment is currently under review by the US FDA and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. Tislelizumab is approved as a treatment in 11 indications in China and is the leading PD-1 inhibitor in this country.

Evidence of clinical efficacy

The EC approval follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on positive results from BeiGene’s RATIONALE 302 study. The Phase III study demonstrated a statistically significant median overall survival rate of 8.6 months for TEVIMBRA versus 6.3 months for chemotherapy.

Tislelizumab reduces risk of death by 30 percent in oesophageal cancer trial

Phase III study RATIONALE 302 investigated the efficacy and safety of TEVIMBRA when compared with investigator’s choice chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC. The study enrolled 513 patients.

“The global RATIONALE 302 trial demonstrated the anti-PD-1 antibody tislelizumab prolonged the survival of patients with locally advanced or metastatic ESCC who had received prior systemic treatment, with no new safety signals identified,” stated Professor Florian Lordick, Director and Professor of Oncology of the University Cancer Center Leipzig, Germany.

Regarding the main clinical studies exploring tislelizumab’s efficacy in other cancers/lines of treatment, the development programme for the anti-PD-1 antibody “encompasses 21 registration-enabling clinical trials in more than 30 countries and regions,” Professor Lordick shared with EPR. “To date, BeiGene has announced positive readouts from 10 Phase III pivotal studies across multiple tumour types and disease settings such as NSCLC, small cell lung cancer, gastric cancer, ESCC, hepatocellular cancer, and nasopharyngeal cancer.”

Changing the treatment landscape for oesophageal cancer

Professor Lordick told EPR how the European approval of tislelizumab changes the landscape of treatment options for advanced or metastatic ESCC. “[Since] more than two-thirds of [oesophageal cancer] patients have advanced or metastatic disease at the time of diagnosis, with a median survival of just eight to 10 months, the need for new treatment options is pressing.” Therefore, he declared that European approval of tislelizumab “represents a significant step forward in oesophageal squamous cell carcinoma (ESCC).”

“As the sixth most common cause of cancer-related deaths [globally], oesophageal cancer represents a key part of this landscape, and this approval marks an important milestone in the movement to improve global cancer care,” he added.

In his response, Professor Lordick highlighted that many patients across Europe and globally are still unable to access effective cancer treatments. “The positive results from the studies on tislelizumab will hopefully act as an important step towards increasing access to the benefits of immune checkpoint inhibition for patients with ESCC and beyond.”