J&J data from Phase II NSCLC treatment trial

 Johnson & Johnson has announced results from the Phase II SKIPPirr study of intravenous (IV) RYBREVANT(amivantamab-vmjw) in patients with non-small cell lung cancer (NSCLC).

The open-label study enrolled 40 advanced NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, following disease progression on osimertinib and platinum-based chemotherapy.

All subjects in the trial received oral LAZCLUZE and IV RYBREVANT.

According to the findings, the trial met the primary endpoint of the incidence of infusion-related reactions (IRRs).

Data revealed that a prophylaxis regimen of 8mg dexamethasone taken for two days before the first infusion significantly reduced the IRR rate to 22.5% at Cycle 1 Day 1, compared to a historical incidence rate of 67.4% with standard management.

Patients in the study followed an at-home regimen of oral dexamethasone, taking an 8mg dose twice daily on the two days before and one hour prior to receiving intravenous RYBREVANT.

The treatment, combined with LAZCLUZE, resulted in all IRRs being Grade 1 or 2, with no hospitalisations required.

In addition, no Grade 3 or higher IRR events were reported in the trial.

The safety profile of RYBREVANT and LAZCLUZE, with prophylactic dexamethasone at treatment initiation, was in line with previous studies. No significant rise in adverse events was reported.

Nausea, dyspnea, and hypotension were reported to be the symptoms related to IRRs in the trial.

A fully human bispecific antibody targeting EGFR and MET with immune cell-directing activity, RYBREVANT monotherapy is approved in various markets for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Johnson & Johnson innovative medicine oncology global medical affairs vice-president Mark Wildgust said: “Reducing the risk of IRRs is a critical aspect of improving the overall treatment experience for patients receiving intravenous RYBREVANT and oral LAZCLUZE.

“Incorporating oral dexamethasone into the treatment regimen suggests we can help mitigate this risk, with the goal of allowing patients to continue their therapy with fewer interruptions.”

Johnson & Johnson recently selected Onco360 as its pharmacy partner for the distribution of LAZCLUZE.

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