Three's a crowd as Tecentriq approved in lung cancer

Roche Rituxan approval

Roche/Genentech's cancer immunotherapy Tecentriq has gained FDA approval as a second line treatment for advanced lung cancer.

The approval ups the ante in the non-small cell lung cancer market (NSCLC), where Tecentriq will compete with Merck's Keytruda and BMS' Opdivo for the biggest and potentially most lucrative cancer market.

Already approved in bladder cancer, Tecentriq (atezolizumab) is predicted to be one of the big launches of the year, with EP Vantage predicting sales of around $2.6 billion.

The FDA approved the drug in patients with non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has EGFR or ALK gene abnormalities.

Significantly, patients do not have to screened for PD-L1 expression before starting treatment. This is the same as Opdivo, while patients taking Keytruda must be tested for the biomarker.

Tecentriq is the first PD-L1 inhibitor immonotherapy to be approved, with Merck KGaA/Pfizer and AstraZeneca lagging behind with avelumab and durvalumab respectively.

Like PD-1 inhibitors, Tecentriq works by overcoming tumours' defence systems that allow them to hide from the body's immune systems.

Tecentriq targets a ligand that binds to to PD-1, and flips a chemical switch that re-instructs T-cells to attack tumours.

Approval was based on the phase 3 OAK and phase 2 POPLAR studies. OAK, a randomised study involving 1,225 people, showed Tecentriq helped people in the study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy.

The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

Tecentriq's development programme includes more than 15 trials, including seven phase 3 trials in previously untreated lung cancer.

These studies evaluate Tecentriq alone or in combination with other therapies.

Investigators say Tecentriq has a slightly different side-effect profile to its PD-1 rivals. Possible serious side effects include lung problems (pneumonitis), liver problems (hepatitis), intestinal problems (colitis) and hormone gland problems (especially the pituitary, thyroid, adrenal glands and pancreas).

Tecentriq will mount a strong challenge, but both Merck and BMS have a head start with their treatments. While BMS's Opdivo is vulnerable after its failure in trials examining it as a first line monotherapy in NSCLC, Keytruda is poised to gain a licence by 24 December, when the FDA is due to make its decision.

Roche's B-First study of Tecentriq in the first line NSCLC setting isn't due to complete until January 2019, however, which should give Merck plenty of time to establish itself in this frontline use.