Border Disease

Rybrevant with chemotherapy is the first treatment to offer prolonged progression-free survival for EGFR-mutated non-small cell lung cancer (NSCLC) patients for whom prior therapy has failed. Credit: Shutterstock/Nattakorn_Maneerat The European Commission (EC) has approved a Type II extension for Johnson and Johnson (J&J)’s immunotherapy Rybrevant (amivantamab), which was submitted in February of this year. Rybrevant in with chemotherapy is the first combination to significantly improve progression-free survival (PFS) versus chemotherapy alone. The European designation follows a similar approval in the US, where the Food and Drug Administration (FDA) granted full approval to Rybrevant plus chemotherapy to treat NSCLC in March this year, upgrading a prior accelerated approval given in May 2021. This label extension describes Rybrevant’s use in combination with carboplatin and pemetrexed to treat NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or exon 21 L958R substitution following prior EGFR TKI therapy. Last week, the FDA also approved Rybrevant plus Lazcluze (lazertinib) combination to treat certain groups of metastatic non-small cell lung cancer (NSCLC). Rybrevant’s latest label expansion was based on data from the Phase III MARIPOSA-2 trial (NCT04988295). The trial investigated the efficacy and safety of Rybrevant plus chemotherapy versus chemotherapy alone for 657 NSCLC patients with certain EGFR mutations for whom osimertinib treatment had failed. Osimertinib is an EGFR TKI marketed as Tagrisso by AstraZeneca . The MARIPOSA-2 trial met its primary endpoint, with Rybrevant reducing the risk of disease progression or death by 52% versus chemotherapy. Patients receiving Rybrevant had a median PFS of 6.3 months compared to 4.2 months for chemotherapy-treated patients, with an objective response rate 64% compared to 36% with the comparator arm. See Also: Singapore approves mpox vaccine as it adds border infection checks EC approves Roche’s monoclonal antibody PiaSky to treat PNH The EGFR+ NSCLC treatment space is highly competitive. GlobalData estimates that Rybrevant will generate $356m in global revenue during 2024, and projects this will increase to $2.4bn annually by 2030. GlobalData is the parent company of Pharmaceutical Technology . Lung cancers account for the greatest mortality of all cancers, killing an estimated 1.8 million people globally in 2020, as per the World Health Organization. NSCLC makes up 85% of lung cancer cases, and of these some of the most common drivers are EGFR mutations. For patients with advanced NSCLC with EGFR mutation who are treated with TKIs, fewer than 20% survive for five years or more. Dr. Henar Hevia, Senior Director of Oncology at Johnson & Johnson , stated that the approval, “addresses a major unmet need for those whose disease has progressed following treatment with an EGFR TKI and who, until now, have faced limited treatment options”.

MSD’s Winrevair has been approved to treat pulmonary arterial hypertension (PAH), a disorder which is caused by high blood pressure in the lungs. Credits: MMD Creative/Shutterstock.com The European Commission (EC) has granted approval to Merck & Co’s (MSD) Winrevair (sotatercept) to be used as a combination therapy for the treatment of adults with functional class II or III pulmonary arterial hypertension (PAH). The approval was awarded based on data from STELLAR, a Phase III study (NCT04576988) that evaluated 323 adult participants with functional class II or III PAH, as determined by the World Health Organization (WHO), as per the 26 August press announcement, The European approval for the subcutaneously administered therapy follows one from the US Food and Drug Administration (FDA) in March 2024 for the same group of PAH patients. According to GlobalData’s consensus forecasts, Winrevair is expected to generate total sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology . Notably, a day before the approval of Winrevair, the FDA granted approval to Johnson & Johnson ’s (J&J) Opsynvi (macitentan + tadalafil). Opsynvi is approved to treat adult patients with WHO Group 1 and functional classes II and III PAH. According to study results published in the New England Journal of Medicine, Winrevair demonstrated a median change in 6-minute walk distance (6MWD) from baseline of 34.4m, which was superior to the 1.0m with placebo at 24 weeks, the study’s primary efficacy endpoint. While the number of reported adverse events was similar in the treatment and placebo groups (138 vs. 140), participants receiving Winrevair experienced more frequent cases of epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure. See Also: Singapore approves mpox vaccine as it adds border infection checks EC approves Roche’s monoclonal antibody PiaSky to treat PNH Winrevair is a first-in-class activin signaling inhibitor designed to increase exercise capacity by binding to several TGF beta superfamily ligands and blocking their signals that contribute to the progression of PAH. As the first approved PAH therapy targeting the activin signaling pathway, the EC approval of Winrevair is an “important step for patients,” said Dr. Joerg Koglin, MSD senior VP and head of general medicine, global clinical development at Merck Research Laboratories. MSD is committed to further investigation of Winrevair in areas of “unmet needs in the management of PAH,” Koglin added. PAH is a rare, blood vessel disorder characterised by the narrowing of the small blood vessels in an individual’s lungs, which results in high blood pressure (hypertension) in the pulmonary artery. MSD is one of several companies developing treatments for PAH. In 2023, GlobalData tracked 129 drugs in development for PAH, nine of which were under development by institutes and universities.