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Tecentriq combo gains European NSCLC approval

Triple combination approved after targeted therapy

roche

Roche has gained approval for checkpoint inhibitor Tecentriq in second line lung cancer as part of a three-drug cocktail.

In combination with chemotherapy and Roche’s older cancer treatment Avastin, Tecentriq can now treat those with EGFR mutant, or ALK-positive metastatic non-squamous non-small cell lung cancer (NSCLC).

The regimen is approved only after the failure of appropriate targeted therapies though, including AstraZeneca’s Tagrisso and Iressa.

The approval will help Tecentriq compete with Merck Sharp & Dohme’s Keytruda, which has emerged as the out-and-out leader in lung cancer immunotherapy, thanks to a string of strong trial results across tumour types and settings. However Tecentriq is still trailing Keytruda in the vital first line use market, where Roche's drug stumbled last year with its non-squamous NSCLC combination in the IMpower 132 study.

Nevertheless the new approval helps Roche gain ground in lung cancer, and gained approval based on some robust phase 3 results.

The IMpower150 study demonstrated that Tecentriq, in combination with Avastin and chemotherapy, helped NSCLC patients with EGFR mutations or who are ALK positive, live significantly longer compared with Avastin and chemotherapy alone (19.8 months vs 14.9 months).

Tecentriq

In addition, those in the Tecentriq combo arm saw a reduction in the risk of disease worsening or death by 41% compared to those in the Avastin and chemotherapy group.

Over half (56.4%) of participants in the Tecentriq combination arm also demonstrated tumour shrinkage compared to 40.2% those in the Avastin/Chemo group.

“Today’s announcement makes the combination of Tecentriq, Avastin and chemotherapy available to people in Europe with advanced, non-squamous non-small cell lung cancer.” said Sandra Horning (pictured below), MD, Roche’s Chief Medical Officer and Head of Global Product Development.

“This approval includes EGFR mutant or ALK-positive non-small cell lung cancer after failure of a targeted therapy marking a first for this subgroup of patients, in which there is a significant need for alternative treatment options.”

Roche has a major programme of trials underway evaluating Tecentriq alone or in combination with other medicines.

One of those trials includes assessing the drug in combination with Immantics’ autologous cell therapy IMA101.

The companies hope that it will be able to generate some data, which shows that Tecentriq has the ability to boost IMA101’s efficacy in solid tumours by blocking the checkpoints that inhibit anti-tumour responses.

Article by
Gemma Jones

8th March 2019

From: Regulatory

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