FDA gives Roche’s Tecentriq green light for first-line NSCLC

Roche has won approval from the FDA for its immunotherapy Tecentriq in certain patients with first-line non-small cell lung cancer (NSCLC), a market which is largely dominated by Merck/MSD’s rival Keytruda.

With the new FDA approval, Tecentriq (atezolizumab) is now indicated as an initial treatment for adults with metastatic NSCLC whose tumours have high PD-L1 expression, without EGFR or ALK mutations.

The approval was granted based on results from the phase 3 IMpower110 study, in which Tecentriq improved overall survival by 7.1 months compared to chemotherapy among patients with high PD-L1 tumour expression.

The checkpoint inhibitor also improved upon standard chemotherapy treatment in terms of occurrences of grade 3-4 treatment-related adverse events, with only 12.9% of people receiving Tecentriq experiencing an event compared to 44.1% of those receiving chemotherapy.

Tecentriq is already approved in NSCLC, although this new approval as a first-line monotherapy treatment extends its reach across the market population. The previously approved indication is for use in combination with chemotherapy and Roche’s older cancer antibody Avastin (bevacizumab) as a first-line treatment for non-squamous NSCLC.

Roche’s immunotherapy is also approved in combination with a chemotherapy regimen of Abraxane and carboplatin in NSCLC patients, whose cancer has metastasised and does not have EGFR or ALK mutations.

Despite breaking into the first-line NSCLC market, Roche will face intense competition from Merck/MSD’s PD-1 inhibitor Keytruda (pembrolizumab), which has been approved in this indication since 2016.

That initial approval in NSCLC helped Keytruda to become the forecasted highest selling drug globally by 2024, with Evaluate Pharma predicting Merck/MSD’s drug will reach sales of $24.3bn in 2026.

However, with NSCLC being the most common type of lung cancer in the world, accounting for around 85% of all cases, there seems to be enough room for a range of treatments, including Tecentriq.

Bristol-Myers Squibb is also looking to encroach into the first-line NSCLC market with its combination immunotherapy treatment, consisting of checkpoint inhibitor Opdivo (nivolumab) and low-dose CTLA4 inhibitor Yervoy (ipilimumab).

The FDA also approved BMS’ regimen in this indication last week, although the path to approval has been far from easy for the combination treatment. Earlier this year, BMS dropped its European marketing application for Opdivo/Yervoy in first-line NSCLC, after EU regulators raised serious concerns over the study that formed the basis of the application.

At least in the US, BMS can now challenge Keytruda and newcomer Tecentriq, with a chemotherapy-limited option for patients with progressive NSCLC.