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Sanofi, Regeneron challenge Keytruda with Libtayo lung data

Phase 3 trial stopped early after showing significant improvement in survival

Libtayo

A trial of Sanofi and Regeneron’s PG-1 inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC) has been stopped early after showing a significant improvement in survival.

The data will form the basis of regulatory filings in Europe and the US this year, throwing down a gauntlet to Merck & Co’s rival PD-1 drug Keytruda (pembrolizumab), which dominates the previously-untreated NSCLC market.

In the phase 3 trial, the combination of Libtayo (cemiplimab) decreased the risk of death by around a third (32%) compared to platinum-based chemotherapy in locally advanced or metastatic NSCLC patients whose tumours tested positive for the biomarker PD-L1 in more than 50% of cells.

At a stroke, the data make sixth-to-market PD-1/PD-L1 inhibitor Libtayo a contender in the first-line NSCLC market, and if approved the new indication could accelerate take-up of the drug, which is currently only approved to treat cutaneous squamous cell carcinoma (CSCC), a form of skin cancer.

First-line NSCLC therapy accounted for a big chunk of Keytruda’s $11.1bn in 2019 sales, although its important to note that most of its use comes from combination treatment with chemo.

Keytruda is also cleared for use as a monotherapy in newly-diagnosed patients, but tends to be reserved for use in those unable to tolerate chemo drugs. Merck’s drug showed a similar improvement in survival compared to chemo in its monotherapy trial, which also included patients with PD-L1 expression of 50%-plus.

That said, not all the PD-1/PD-L1 inhibitors have been able to improve on chemo in first-line NSCLC. Bristol-Myers Squibb’s Opdivo (nivolumab) failed as a monotherapy and in combination with chemo, for example, so the data are clearly a positive for Libtayo’s future prospects as Sanofi and Regeneron try to widen the indications for the drug.

Some analysts suggest approval could push the product’s annual sales well above the $1bn mark. Sanofi reported Libtayo sales of €16m last year from the drug’s initial roll-out in seven countries outside the US, where it is sold by Regeneron. It added another €12m in the first quarter of 2020. Regeneron meanwhile recorded $176m in Libtayo sales in the US last year.

“While demonstrating a survival benefit in first-line NSCLC has been challenging for immunotherapies, the one FDA-approved anti-PD-1 monotherapy has changed the therapeutic paradigm,” said Regeneron’s chief scientific officer George Yancopoulos.

“We are pleased with the results of this trial that demonstrate the survival benefit of Libtayo in these patients and hope it may become a potential alternative for physicians and patients,” he added.

Keytruda is also facing competition in the monotherapy category from Roche’s Tecentriq (atezolizumab) however, which is heading for an FDA verdict in June on the back of the IMpower110 study.

That trial showed that Tecentriq monotherapy improved overall survival by 7.1 months compared with chemotherapy in people with high PD-L1 expression.

BMS meanwhile is trying to muscle into the first-line setting with a chemo-free regimen of Opdivo with CTLA4 inhibitor Yervoy (ipilimumab), with a decision from the FDA due next month as a first-line option for treatment-naïve NSCLC patients whose tumours don’t have EGFR or ALK mutations.

A second phase 3 trial investigating the first-line combination of Libtayo plus chemo in patients with advanced NSCLC irrespective of PD-L1 expression is also under way and if positive could help the drug compete head-to-head with Keytruda. Results are due in 2023.

Article by
Phil Taylor

28th April 2020

From: Research

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