GSK and J&J secure key EU approvals for expanding cancer therapies

BELGIUM – GSK and Johnson & Johnson (J&J) have both received new approvals from the European Commission, paving the way for expanded use of their leading cancer treatments and driving sales growth for these pivotal drugs.

GSK achieved a significant milestone with the approval of its PD-1 inhibitor, Jemperli (dostarlimab), in combination with chemotherapy as a first-line treatment for all adult patients with primary advanced or recurrent endometrial cancer.

This approval marks a critical step in GSK’s ambitions to position Jemperli as a blockbuster therapy.

The decision was based on findings from the RUBY Part 1 trial, which demonstrated that Jemperli combined with carboplatin and paclitaxel reduced the risk of death by 31% compared to chemotherapy alone.

After two and a half years, the median overall survival (OS) reached 44.6 months with Jemperli versus 28.2 months with chemotherapy alone.

Notably, this expanded label now includes patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumors, which represent 75% of endometrial cancer cases.

Until now, Jemperli’s use in the EU was limited to mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, a restriction since its 2023 approval.

This makes Jemperli only the second PD-1/PD-L1 inhibitor with this broad indication in the EU, following Merck & Co.’s Keytruda (pembrolizumab).

However, Jemperli stands apart by demonstrating overall survival benefits, strengthening GSK’s pursuit of turning it into a US $1 billion-plus blockbuster therapy.

Simultaneously, J&J secured European approval for its combination therapy of Rybrevant (amivantamab), an EGFRxMET bispecific antibody, with the third-generation EGFR tyrosine kinase inhibitor Lazcluze (lazertinib).

The duo is now cleared as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring exon 19 deletions or exon 21 L858R substitutions.

This approval is underpinned by data from the MARIPOSA trial, which demonstrated a 30% reduction in the risk of disease progression or death compared to AstraZeneca’s market-leading EGFR inhibitor, Tagrisso (osimertinib).

Early results also suggest an improvement in overall survival compared to Tagrisso, with J&J hinting that the survival benefits could exceed one year.

J&J has positioned Rybrevant/Lazcluze as a transformative treatment option for NSCLC, enhancing Rybrevant’s growth trajectory.

This approval complements its recent clearance as part of a frontline regimen with chemotherapy for NSCLC patients with rare EGFR exon 20 mutations, based on the PAPILLON trial.

Together, these developments aim to elevate Rybrevant into a US $5 billion-a-year product.