Johnson & Johnson (J&J) has announced that an injectable version of Rybrevant (amivantamab) has been recommended by the European Medicines Agency’s human medicines committee for two lung cancer indications.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the subcutaneous (SC) formulation be approved as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
The committee has also recommended that SC Rybrevant be approved as a monotherapy for adults with advanced NSCLC with activating EGFR exon 20 insertion mutations who have failed platinum-based therapy.
An estimated 484,306 people in Europe were diagnosed with lung cancer in 2022, with NSCLC accounting for approximately 85% of all cases.
Rybrevant is a fully-human EGFR-MET bispecific antibody already approved in the EU to treat certain NSCLC patients as an intravenous (IV) infusion.
It is hoped that the SC formulation, co-formulated with Halozyme’s Enhanze drug delivery technology, will improve the treatment experience for patients by significantly reducing administration time while also lowering rates of infusion-related reactions.
The CHMP’s recommendations were supported by positive results from the late-stage PALOMA-3 study, which demonstrated that SC Rybrevant was non-inferior to IV Rybrevant.
At a median follow-up of seven months, the overall response rate was 30% in the SC group and 33% for IV. Administration time for SC Rybrevant was also reduced to around five minutes compared to around five hours for the first IV Rybrevant infusion, and there was a five-fold reduction in infusion-related reactions in the SC arm.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, said SC Rybrevant “[provides] the established efficacy benefits of IV [Rybrevant] with improved safety outcomes and greater convenience for patients”.
Joshua Bauml, vice president, lung cancer disease area stronghold leader, J&J Innovative Medicine, added: “We look forward to bringing this new treatment option to patients in Europe, as we advance our ambition to transform outcomes in EGFR-mutated NSCLC.”
The European Commission will now consider the CHMP’s recommendations as it makes a decision on SC Rybrevant in these indications.