Moe Alsumidaie, Chief Editor at The Clinical Trial Vanguard, shared on LinkedIn:
“NEWS:
Johnson & Johnson’s subcutaneous amivantamab plus lazertinib cut side effects dramatically in NSCLC patients who struggled to stay on the IV version.
Phase 2b COPERNICUS data, presented at WCLC 2026, show the reformulated regimen with oral anticoagulation and an enhanced skin-care protocol slashed three of the most burdensome toxicities that plagued the pivotal MARIPOSA trial.
The data:
- Rash: 55% (MARIPOSA) vs. 25% (COPERNICUS)
- Infusion/administration-related reactions: 55% vs. 3%
- Venous thromboembolism: 23% vs. 3%
- Only 8% of 214 patients discontinued due to adverse events at median 8.3 months follow-up
- Less than 1% stopped at one year due to treatment-related events
Why it matters: MARIPOSA already proved a survival edge over osimertinib (HR 0.75, p=0.005), but an OS benefit only holds commercially if community oncologists can keep patients on therapy.
COPERNICUS was designed around that exact concern, enrolling a mixed academic and community population, with a median age of 67, 22% of patients aged 75 or older, 10% African American, and 10% Hispanic/Latino, demographics rarely seen in EGFR-mutated NSCLC trials.
How it works: Johnson & Johnson’s RYBREVANT FASPRO delivers amivantamab subcutaneously across all approved indications after FDA clearance in December 2025, paired with oral lazertinib and prophylactic strategies to blunt the toxicities that drove discontinuation in the IV era.
What’s next: COPERNICUS is targeting 300 patients total.
The primary endpoint is investigator-assessed progression-free survival, and that readout will determine whether tolerability gains translate into a standalone outcome signal beyond MARIPOSA’s survival data.
Does reducing toxicity in community settings matter as much as the survival data when it comes to real-world coverage decisions?
Title: Amivantamab-lazertinib combo shows lower side effects in Phase 2b trial
Author: Jon Napitupulu.
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Mark Wildgust, Vice President of Global Medical Affairs, Oncology at The Janssen Pharmaceutical Companies of Johnson and Johnson, added on LinkedIn:
“Helping patients with more tomorrows is important but also better today’s.
Patient experience while living as they fight their cancer is so important.
At Johnson & Johnson Innovative Medicine we are working to advance new innovations to eliminate cancer but also advancing approaches to help patients live well.
COPERNICUS Is a wonderful example of that.
Congratulations to my colleagues Mahadi Baig and his team.”
You can also read: MARIPOSA: Amivantamab Plus Lazertinib Reduces EGFR/MET Resistance and Extends Second-Line Disease Control in EGFR-Mutated NSCLC
