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Johnson & Johnson JNJ announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving the combination of its intravenously administered EGFR/MET inhibitor Rybrevant (amivantamab) and oral EGFR-TKI inhibitorLazcluze (lazertinib) for use in certain patients with non-small cell lung cancer (NSCLC).
The CHMP has recommended the Rybrevant-Lazcluze combination as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution (L858R) mutations. The FDA approved this combination in August for a similar indication.
This recommendation is based on data from the phase III MARIPOSA study, which evaluated the Rybrevant-Lazcluze combo against AstraZeneca’s AZN blockbuster oncology drug Tagrisso in patients with the above indication.
Data from the MARIPOSA study showed that treatment with the JNJ combination therapy reduced the risk of disease progression or death by 30% compared with AZN’s Tagrisso. Patients who took the combo achieved a median duration of response (mDOR) that was nine months longer than those treated with the AstraZeneca drug.
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Recent Developments Related to JNJ's Rybrevant
In August, the European Commission approved the combination of Rybrevant and standard-of-care chemotherapy (carboplatin and pemetrexed) for treating adult patients with advanced NSCLC with EGFR ex19del or L858R mutations after failure of prior therapy, including an EGFR-TKI. This combination received the FDA’s approval for use in a similar indication in September.
Rybrevant also received approval for a third indication in the United States. In March, the FDA approved the combination of Rybrevant and chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The combination is also approved for a similar indication in the EU.
Through these approvals, the J&J drug intends to take on AstraZeneca’s Tagrisso, which is the current standard of care for EGFR-mutated NSCLC.
In June, J&J submitted a regulatory filing with the FDA seeking approval for a subcutaneous formulation of Rybrevant for all currently approved or submitted indications of the drug. Per management, the FDA granted this filing a priority designation in August.
Apart from NSCLC, J&J is also evaluating Rybrevant in other cancer indications. In September, management reported new data from the phase Ib/II OrigAMI-1 study, which evaluated the combination of Rybrevant plus chemotherapy in certain patients with metastatic colorectal cancer. Patients who received the combo therapy achieved an overall response rate of 49% and a disease control rate of 88%.