Janssen receives positive CHMP opinion for RYBREVANT® (amivantamab) for treatment of patients with advanced non-small cell lung cancer with EGFR exon 20 insertion mutations after failure of platinum-based therapy

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product amivantamab, intended for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy.

If approved, amivantamab will be the first treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for advanced NSCLC.

“This group of patients often face a poor prognosis as there are currently no targeted therapy options for this specific mutation nor does it typically respond to existing therapies used to treat more common EGFR mutations,” said Catherine Taylor, M.D., Vice President,
Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag AG.

“The decision today by the CHMP recognises amivantamab has the potential to
provide an urgently required, effective and tolerable new treatment option specifically
targeted for patients diagnosed with non-small cell lung cancer who have EGFR exon 20
insertion mutations.”

Amivantamab is a fully-human EGFR and MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistant EGFR and MET mutations and amplifications. The European marketing authorisation application (MAA) is based on results from the Phase 1 CHRYSALIS study, a multicentre, open-label, clinical study evaluating amivantamab as a monotherapy in patients after previous treatment with
platinum-based therapy, which demonstrated efficacy and a generally well-tolerated safety

Confirmed complete or partial responses were observed in 32 out of 81 patients,
resulting in an overall response rate of 40 percent (95 percent CI, 29% – 51%), with a
median duration of response of 11.1 months (95 percent CI, 6.9 – not reached). The
median progression free survival (time experienced without progression or death) was 8.3
months (95 percent CI, 6.5 – 10.9) and the median overall survival in patients treated with
amivantamab was 22.8 months (95 percent CI, 14.6 – not reached).

The most common adverse events (AEs) were predominantly Grade 1-2 and included
infusion-related reactions (66 percent), rash (86 percent) and paronychia (45 percent).
Sixteen percent of patients experienced treatment-related Grade ≥3 AEs. Treatment-related discontinuations were seen in four percent and treatment-related dose reductions in
13 percent of patients. There were no treatment-related deaths.

Ninety-four percent of infusion related reactions (IRRs) occurred with the first infusions and rarely impacted the ability to continue with subsequent treatments. Initial study results from the CHRYSALIS EGFR exon 20 insertion mutation population were presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program and updated results were presented at the IASLC World Conference on Lung Cancer (WCLC) 2020.

“Amivantamab has the potential to address the high unmet need in the treatment of people
with EGFR exon 20 insertion mutations in non-small cell lung cancer,” said Peter Lebowitz,
M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development,

“At Janssen, we are committed to delivering innovative therapies and making a
meaningful impact in areas of high unmet need and in the lives of patients. With the
development of a novel bispecific antibody like amivantamab, we believe advancing
medicines targeting specific pathways can bring the greatest benefits and improve
outcomes for patients with tumour alterations, such as EGFR and MET.”

The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which is expected later this year. The U.S. Food and Drug Administration (FDA) approved amivantamab in May 2021 for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Additional regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.

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