dm+d

Unassigned

New Medicines

RybelvantMetastatic or unresectable non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertions - relapsed after platinum-based chemotherapy

Information

Rybelvant
New molecular entity
Janssen
Johnson & Johnson

Development and Regulatory status

Phase II Clinical Trials
Pre-registration (Filed)
Approved (Licensed)
May 21Approved in US [9].
Dec 20MAA submitted to the European Medicines Agency (EMA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) [7].
Dec 20Janssen submit BLA to US FDA for amivantamab with indication of ´treatment of patients with metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy´ [5].
Apr 20Filings planned for 2023 at the latest [4].
Mar 20US FDA grants breakthrough therapy status for JNJ 6372 for the treatment of patients with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy [3].

Category

A fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and proto-oncogene protein c-met
There were 46,403 new cases diagnosed in the UK in 2014. 53% were males and 47% were females. NSCLC account for 85% of cases [1].
Metastatic or unresectable non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertions - relapsed after platinum-based chemotherapy
Intravenous infusion

Further information

Yes
October 2022

Trial or other data

Sep 21Company announces analysis data from CHRYSALIS trial at the ESMO Congress 21. An overall response rate of 36% and median duration of response of 9.6 months was observed in pts receiving combination of amivantamab + lazertinib (n=45). Whereas, an overall response rate of 19% and median duration of response of 5.9 months was observed in pts receiving amivantamab monotherapy (n=121). The clinical benefit rate was 64% in the combination group vs 48% in the monotherapy group. The combination group experienced central nervous system progression in 7% of pts (4% new lesions) vs 17% of pts with CNS progression (13% new lesions) in the monotherapy group. The safety profiles for both combination and monotherapy were consistent with previously reported data [10].
Jan 21J&J announce amivantamab (n=81) shrank tumours in 40% of lung cancer patients with a rare EGFR mutation and curbed tumour growth in ~75% of patients. Of the 40% of patients who saw their tumors shrink, three patients (4%) experienced complete remission. Medium response rate was 11 months and progression free survival was 8.3 months. Rash and infusion related reactions were the most commonly reported side-effects [8].
Dec 20PI/II CHRYSALIS trial (NCT02609776) is still recruiting [2].
Mar 20PI/II trial (NCT02609776) is recruiting [2].
May 16First-in-human, two-part, PI trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of JNJ 61186372 as a monotherapy and in combination with lazertinib, and to determine the recommended phase II dose regimen in patients with advanced NSCLC starts (NCT02609776). Part 1 is a 3+3 designed dose-escalation cohort and Part 2 is a dose expansion cohort. The trial intends to enrol 460 adults in Australia, Canada, China, France, Japan, South Korea, Spain, Taiwan, the UK and the US. Collection of primary outcome data is due to complete Mar 21 [2].

Evidence based evaluations

RybelvantNon-small cell lung cancer (NSCLC) with EGFR Exon 20 insertions - first-line with carboplatin-pemetrexed chemotherapy

Information

Rybelvant
Licence extension / variation
Janssen
Johnson & Johnson

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and proto-oncogene protein c-met
A fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and proto-oncogene protein c-met
Non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertions - first-line with carboplatin-pemetrexed chemotherapy
Intravenous infusion