Roche scores EU approval twice for Tecentriq in lung cancer

Roche continues to edge its way into the lung cancer market following the European Commission marketing approval of its cancer immunotherapy Tecentriq, in both extensive-stage small cell lung cancer (ES-CLC) and non-squamous non-small cell lung cancer (NSCLC).

Tecentriq has been approved as a first-line treatment option in both indications, in combination with chemotherapy. The approval in ES-CLC is the first cancer immunotherapy approved in Europe in this indication as an initial treatment. The immunotherapy gained FDA approval in this indication earlier this year, which made it the first approval as an initial treatment in ES-CLC for 20 years.

This approval was based on the results from the phase 3 IMpower133 study, which showed that the Tecentriq combination significantly extended life when compared with chemotherapy alone. It also reduced the risk of disease worsening or death.

The prognosis for ES-CLC is particularly poor, with 70% of all small-cell lung cancer cases being diagnosed at this stage. It is aggressive and grows rapidly, often becoming metastatic quickly.

The approval in ES-CLC also gives Roche the opportunity to establish a space in the lung cancer market without competition from other checkpoint inhibitors, particularly MSD’s Keytruda (pembrolizumab), which has the largest market share in lung cancer.

However, MSD is closing the gap, with a current phase 3 trial (KeyNote-604) testing Keytruda in combination with chemotherapy as a first-line treatment for ES-CLC. Bristol-Myers Squibb is also testing its own PD-1 inhibitor Opdivo (nivolumab) in this indication, with a trial currently in phase 2.

Sandra Horning, chief medical officer and head of global product development, Roche

“This approval makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small cell lung cancer, marking an important step forward for patients,” said Sandra Horning (pictured above).

Roche’s second European approval in NSCLC means Tecentriq in combination with chemotherapy is now an available treatment option for the initial treatment of this type of lung cancer, for patients who do not have EGFR mutant or ALK-positive NSCLC.

It is already approved in the treatment of patients with NSCLC which is EGFR-mutant or ALK-positive, so this approval widens the scope for Tecentriq. This most recent approval came following the positive results from the phase 3 IMpower130, which also demonstrated a significant advantage in overall survival and progression free survival when compared to chemotherapy alone.

However, BMS is likely to face tough competition from MSD’s Keytruda, which dominates in the NSCLC area. Although Tecentriq is its closest competitor in this market, it still trails behind Keytruda in terms of revenue and market share.