Abstracts from the OrigAMI-1 and MARIPOSA-2 trials indicated the treatment benefits of amivantamab-vmjw and chemotherapy in multiple cancer indications.
At the European Society of Medical Oncology (ESMO) 2024 Congress, positive results highlighting the role of bispecific antibody amivantamab-vmjw (Rybrevant; Johnson & Johnson) in multiple forms of cancer, including metastatic colorectal cancer (mCRC) and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), were showcased.1,2
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New data from the phase 1b/2 OrigAMI-1 study indicated that amivantamab-vmjw combined with chemotherapy demonstrated durable and rapid antitumor activity in patients with RAS/BRAF wild-type (WT) mCRC who have not previously received anti-EGFR therapy.1,3 Across the trial, 43 patients were treated with amivantamab-vmjw along with chemotherapy, with a median follow-up period of 7.3 months. Those treated with amivantamab-vmjw plus chemotherapy demonstrated an overall response rate (ORR) of 49% (95% CI: 33-65), with a median duration of response (DOR) of 7.4 months (95% CI: 5.6-not estimable).1
Furthermore, disease control was seen in 88% of patients (95% CI: 75-96), and in those with liver metastases, clinically meaningful intrahepatic antitumor activity was demonstrated. In another important result, 21% of patients were able to transition to curative-intent surgery due to the strong antitumor activity of amivantamab-vmjw.1
Trial Name: A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (OrigAMI-1)
ClinicalTrials.gov ID: NCT05379595
Sponsor: Janssen Research & Development, LLC
Estimated Completion Date: April 27, 2027
“OrigAMI-1 is the first study to show Rybrevant plus chemotherapy may provide clinically meaningful benefits to patients with metastatic colorectal cancer who have not received any EGFR-targeted treatments as their first or second line of therapy,” Filippo Pietrantonio, MD, presenting author, said in the news release.1
In terms of amivantamab-vmjw’s safety profile in these patients, adverse effects were manageable and consistent with each of the individual components of the treatment regimen. There was no new safety signals observed, and no grade 3 or higher infusion-related reactions reported.1
Amivantamab-vmjw was further highlighted for treatment in another indication: EGFR-mutated NSCLC. Data from the phase 3 MARIPOSA-2 study was presented, showing that a amivantamab-vmjw and chemotherapy combination led to consistent benefits across post-progression outcomes in adult patients with previously treated EGFR-mutated NSCLC. These data also revealed a favorable trend towards improved overall survival compared to chemotherapy alone.2,4
At the 18-month landmark, 50% of patients treated with amivantamab-vmjw plus chemotherapy were still alive, compared to 40% of those receiving only chemotherapy (median OS, 17.7 vs 15.3 months, respectively; hazard ratio [HR], 0.73; 95% CI: 0.54-0.99). Amivantamab-vmjw performed positively in another critical measure: treatment discontinuation rates. There were nearly 5 times as many patients remaining on therapy at 18 months (22%) compared with chemotherapy (4%), highlighting the durability, safety, and effectiveness of the treatment.2
Trial Name: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure (MARIPOSA-2)
ClinicalTrials.gov ID: NCT04988295
Sponsor: Janssen Research & Development, LLC
Estimated Completion Date: June 30, 2026
“The positive overall survival trend seen in MARIPOSA-2 is incredibly promising, suggesting that amivantamab combined with chemotherapy could potentially change the treatment landscape for a population that has historically faced limited options,” Sanjay Popat, FRCP, PhD, presenting author at ESMO, said in the news release.“Building on the strong progression-free survival data previously reported from this study and by helping more patients stay on treatment for longer, we are improving their chances for better outcomes.”2
Patients treated with amivantamab-vmjw had a 27% reduction in risk of symptomatic progression (16.0 vs 11.8 months; HR, 0.73; 95% CI: 0.55-0.96) compared with placebo. There was also a significantly prolonged time to subsequent therapy for patients treated with the amivantamab-vmjw and chemotherapy combination, another indication of sustained treatment effects.2
Earlier this year, the FDA approved amivantamab-vmjw in combination with Lazertinib (Lazcluze; Johnson & Johnson) for the treatment of adults with locally advanced or metastatic EGFR-mutated NSCLC. The positive data presented at ESMO showcasing the effectiveness of the drug in combination with chemotherapy could lead to regulatory approval of amivantamab-vmjw for other indications that could benefit from the novel treatment.5
