Roche gets FDA nod for Tecentriq in small cell lung cancer

Roche continues to nibble away at the big lung cancer market with its cancer immunotherapy Tecentriq, picking up an FDA approval for first-line extensive-stage small cell lung cancer (ES-SCLC).

The US regulator has cleared Tecentriq (atezolizumab) in combination with chemotherapy for ES-SCLC, making the PD-L1 inhibitor the first cancer immunotherapy to be approved as initial therapy in this cancer and ending a 20-year drought in new therapies for patients.

SCLC is less common than non-small cell lung cancer (NSCLC) but tends to be more aggressive, growing more quickly and spreading to other parts of the body earlier. It’s fairly responsive to chemotherapy and radiotherapy, but relapse rates are high and median survival low – often a year or less in extensive-stage disease where the tumour has spready beyond the lung and adjacent lymph node at diagnosis.

Two-thirds of patients have advanced disease at diagnosis and typically 5% or fewer are still alive after five years.

The FDA approval is based on the results of the IMpower133 trial, which showed that adding Tecentriq to chemotherapy helped people live significantly longer compared to chemotherapy alone with a median survival of 12.3 versus 10.3 months.

Tecentriq also extended the time to disease worsening or death (progression-free survival) to 5.2 months versus 4.3 months for chemotherapy alone. Roche presented top-line findings from the trial last year.

Adding ES-SCLC to Tecentriq’s indications gives Roche an opportunity to carve out another slice of the lung cancer market without competition from other checkpoint inhibitors, particularly Merck & Co/MSD’s PD-1 inhibitor Keytruda (pembrolizumab) which is dominating the NSCLC category.

Merck isn’t too far behind, however, as it is currently running a phase 3 trial (KeyNote-604) of its PD-1 inhibitor as a first-line therapy for ES-SCLC in combination with chemotherapy, and Bristol-Myers Squibb is also testing its PD-1 inhibitor Opdivo (nivolumab) in a phase 2 trial in this indication.

Meanwhile, AstraZeneca is also testing its PD-L1 inhibitor Imfinzi (durvalumab) in first-line ES-SCLC as a monotherapy and in combination with its investigational CTLA4 inhibitor tremelimumab on top of background chemotherapy in the CASPIAN study.

Nevertheless, the approval extends Tecentriq’s position in lung cancer as Roche tries to build momentum behind its flagship immuno-oncology drug.

It recently picked up EU approvals for second-line use in non-squamous NSCLC as a combination with chemotherapy and Roche’s older cancer treatment Avastin (bevacizumab), but suffered a big setback last year when a trial of Tecentriq plus Eli Lilly’s Alimta (pemetrexed) was unable to improve survival as a first-line therapy in non-squamous NSCLC.