Keytruda bags another EU approval in frontline lung cancer

Merck & Co/MSD has tightened its hold on the first-line lung cancer market with another EU approval for Keytruda – this time for its use alongside chemotherapy in patients with metastatic squamous non-small cell lung cancer (NSCLC).

The European approval comes after Keytruda was approved for this indication in the US last October, and is great news for patients with squamous forms of NSCLC who have seen treatment advances – and particularly cancer immunotherapies – lag behind other NSCLC subtypes.

Keytruda’s approval in squamous NSCLC comes on the back of the KEYNOTE-407 trial reported at last year’s ASCO meeting, which showed that combining the PD-1 inhibitor with either generic carboplatin or nab-paclitaxel, the active ingredient in Celgene’s Abraxane and various generic rivals in Europe, improved overall survival.

Many patients with advanced squamous NSCLC are still being treated with chemotherapy, although Keytruda has been approved as a monotherapy for patients with PD-L1-expressing squamous tumours since 2015.

The all-comer approval for the combination regimen extends the number of squamous NSCLC patients eligible for treatment with Keytruda, and consolidates its already-dominant position in first-line NSCLC that allowed it to overtake arch-rival Opdivo (nivolumab) from Bristol-Myers Squibb in sales terms last year.

Squamous NSCLC is less common than non-squamous forms but still accounts for around a third of all cases and is notoriously hard to treat. The combination approval promises to usher in a new standard-of-care for patients, with Keytruda monotherapy still an option for patients too ill to handle chemotherapy.

“Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer,” commented Dr Luis Paz-Ares of the Hospital Universitario Doce de Octubre in Madrid, Spain, who was one of the principal investigators in KEYNOTE-407.

The approval is another boost for Celgene’s Abraxane, which has benefited from a string of new licenses in combination with immuno-oncology drugs in the last few months, including a green light in the US alongside Roche’s Tecentriq (atezolizumab) in triple-negative breast cancer a few days ago.

Abraxane is however facing generic competition in Europe having lost patent protection last year, although Celgene is claiming market exclusivity in the US until at least 2022.

Roche also has eyes on the first-line squamous NSCLC market, and at ASCO in 2018 reported interim results from the IMpower131 study of Tecentriq plus chemotherapy in this setting.

That revealed a benefit for the combination versus chemotherapy alone in progression-free survival (PFS), but failed to show any improvement in overall survival at ASCO. It missed the mark on that measure once again in an update presented at the ESMO conference last October, handing the advantage to Keytruda for the time being.

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