Janssen, a pharmaceutical company of the Johnson & Johnson group, announced today that it has obtained conditional marketing authorization for amivantamab in the treatment of adults with lung cancer Advanced non-small cell (NSCLC), characterized by EGFR activating exon 20 insertion, after platinum-based therapy failure.1 Amivantamab is the first-ever treatment approved in the European Union for this specific malignancy.
Marketing Authorization conditionality consists in the approval of a drug, which responds to patient needs not yet satisfied, on the basis of less complete data than is normally required, where the benefit deriving from the immediate availability of the drug outweighs the risk. The applicant for authorization will provide more comprehensive clinical data at a later stage.
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“NSCLC patients with EGFR exon 20 insertion mutations have few therapeutic options, both in number and efficacy.5 The decision of the European Commission represents an important milestone because it recognizes that amivantamab is a new type of treatment, specifically aimed at patients with lung cancer who present this type of alteration” commented Antonio Passaro, medical oncologist of the Thoracic Oncology Division of the European Institute of Oncology in Milan.
The conditional marketing authorization is based on the Phase 1 CHRYSALIS study, an open-label, multicenter clinical study evaluating amivantamab monotherapy in patients previously treated with platinum-based therapy and which has demonstrated its efficacy. and a generally well tolerated safety profile.
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The investigator-assessed overall response rate observed in the study was 37 percent (95% CI, 28% – 46%), with an overall median duration of response of 12.5 months (95% CI, 6.5 – 16.1) and 64 percent of patients had a duration of response of 6 months or more.4 These results are consistent with those reported by the Blinded Independent Central Review (BICR), which presented a response rate of 43 percent (34% – 53%), with a median duration of response of 10.8 months ( 95% CI, 6.9 – 15.0) and 55 percent of patients with a duration of response of 6 months or more.
Analyzes have shown, in patients treated with amivantamab, a median progression-free survival (time elapsed without progression or death) of 8.3 months (95% CI, 6.5 – 10.9) and a median overall survival of 22.8 months (95 % CI, 14.6 – not reached).
The most common adverse events (AEs) of any grade included rash (76 percent), infusion-related reactions (67 percent), and paronychia (47 percent), predominantly grade 1-2.4 Discontinuations due to adverse events were observed in 3 percent of patients.4 99 percent of infusion-related reactions (IRRs) occurred with the first infusions and rarely affected the ability to continue subsequent treatments (1.1% led to treatment discontinuation).
“The marketing authorization responds to the still unmet need to offer, for the first time in Europe, a new treatment option for this type of cancer to patients and healthcare professionals. This is an important step towards our goal of providing innovative therapies that transform the course of lung cancer“, commented Peter Lebowitz, M.D., Ph.D, Global Therapeutic Area Head Oncology, Janssen Research & Development, LCC.
The US Food and Drug Administration (FDA) had already approved in May 2021 amivantamab for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating exon 20 insertion progressed with or after platinum-based chemotherapy.8 Further approval requests have been submitted and are also being reviewed by other regulatory bodies around the world.
“We are committed to changing the way we care for cancer patients“, commented Mathai Mammen, M.D., Ph.D, Global Head, Janssen Research & Development, Johnson & Johson. “At Janssen, we work to transform patients’ long-term outcomes and improve their quality of life with the right therapy, at the right time.”
amivantamab
Amivantamab is a fully human EGFR-MET bispecific antibody with cellular immunity-mediated activity that acts on EGFR activating and resistance mutations and MET activation pathways, approved for EGFR advanced non-small cell lung cancer (NSCLC) patients -mutated with insertion of exon 20, following the failure of platinum-based therapy.
Non-small cell lung cancer (NSCLC)
In Europe, an estimated 477,534 patients were diagnosed with lung cancer in 2020, with approximately 85 percent of NSCLC. Lung cancer is the cancer that causes more deaths on the continent, even than are caused by breast cancer and prostate cancer combined.
The major subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. Among the most common mutations in NSCLC are those in the gene encoding the epidermal growth factor receptor (EGFR), a tyrosine kinase receptor that helps cells proliferate and divide. EGFR mutations are present in 16-19 percent of Caucasian patients with NSCLC and present in 37-41 percent of Asian patients. The five-year survival rate for all people with metastatic NSCLC and EGFR mutations who are treated with EGFR TKIs is less than 20 percent. Patients with EGFR exon 20 insertion mutations have a five-year real-world overall survival (OS) of 8 percent in the first-line setting, which is worse than patients with EGFR exon 19 deletions or L858R mutations, which have a real-world five-year OS of 19 percent.