EU approves endometrial, lung cancer drugs from GSK and J&J

GSK and Johnson & Johnson have picked up new approvals from the European Commission for new indications that are poised to unlock sales growth for key cancer medicines.

First up GSK, which got a green light for its PF-1 inhibitor Jemperli (dostarlimab) in combination with chemotherapy as a first-line treatment for all adult patients with primary advanced or recurrent endometrial cancer, a key part of the company's growth ambitions for the drug.

The expanded approval is based on the RUBY Part 1 trial, which showed that Jemperli (dostarlimab) given with carboplatin and paclitaxel chemotherapy achieved a 31% reduction in the risk of death compared to chemo alone after two and a half years, with median overall survival (OS) of 44.6 months and 28.2 months, respectively.

Crucially, the new label includes mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, which account for 75% of all endometrial cancer cases. Jemperli has been approved in the EU with a restricted label that limited its use to patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumours since 2023.

Jemperli is only the second drug in the PD-1/PD-L1 inhibitor class with this indication in the EU after MSD's Keytruda (pembrolizumab), which was approved based on progression-free survival only – and the indication is viewed as being critical to GSK's ambition to build the drug into a $1 billion-plus blockbuster.

Meanwhile, J&J has claimed EU approval for its combination of EGFRxMET bispecific antibody Rybrevant (amivantamab) with third-generation EGFR tyrosine kinase inhibitor Lazcluze (lazertinib) as a first-line treatment for locally advanced and metastatic NSCLC with exon 19 deletions or exon 21 L858R substitutions.

The approval is supported by results from the MARIPOSA study, which showed that the chemotherapy-free regimen reduced the risk of disease progression or death by 30% compared to monotherapy with AstraZeneca's Tagrisso (osimertinib), which currently dominates the EGFR inhibitor market.

J&J reported top-line data showing that OS was also improved compared to Tagrisso earlier tis month and, while that data hasn't been presented yet, the company has suggested it looks likely to exceed one year.

The company reckons that Rybrevant/Lazcluze represents a major step forward in treatment for this type of lung cancer, and will be pivotal in growing Rybrevant into a $5 billion a year product along with its recent approval in combination with chemotherapy as a frontline regimen for NSCLC patients with less frequent EGFR exon 20 mutations based on the PAPILLON trial.

Main image: EmDee, CC BY-SA 4.0, via Wikimedia Commons