Express | Treatment of specific non-small cell lung cancer, FDA accelerates approval of Janssen bispecific antibody precision therapy

▎The content team editor of WuXi AppTec today, the U.
S.
FDA announced that it has approved the listing of the EGFR/MET bispecific antibody therapy Rybrevant (amivantamab-vmjw) developed by Janssen, a subsidiary of Johnson & Johnson, for the treatment of insertion mutations carrying EGFR exon 20 Of patients with non-small cell lung cancer (NSCLC).

The press release states that this is the first precision therapy approved by the FDA for the treatment of this patient group.

It is worth mentioning that this bispecific antibody therapy has been included as a breakthrough treatment product by the National Food and Drug Administration (NMPA) of China.
A number of clinical trials are currently underway in China, including the third-generation EGFR tyrosine kinase inhibition.
Lazertinib is used in combination to treat locally advanced or metastatic non-small cell lung cancer with EGFR mutations as the first-line treatment.

NSCLC accounts for 80%-85% of all lung cancers.

The most common driver mutation is EGFR gene mutation, EGFR is a receptor tyrosine kinase that supports cell growth and division.

EGFR mutations occur in 40%-50% of Asian patients, and all patients with metastatic NSCLC treated with EGFR tyrosine kinase inhibitors have a 5-year survival rate of less than 20%.

About 2-3% of NSCLC patients carry EGFR exon 20 insertion mutations.
These patients do not respond well to ordinary EGFR inhibitors, and the prognosis is particularly poor.

Rybrevant is a humanized EGFR/MET bispecific antibody.

It has multiple anti-cancer mechanisms.
It can not only block EGFR and MET-mediated signal transduction, but also guide immune cells to target tumors that carry activating and resistant EGFR/MET mutations and amplifications.

▲Amivantamab can kill NSCLC cells through a variety of mechanisms (picture source: reference [2]) FDA's approval is based on a clinical trial involving 81 patients.

The NSCLC patients who participated in the trial carried EGFR exon 20 insertion mutations and their disease continued to progress after receiving platinum-containing chemotherapy.

The trial results showed that Rybrevant achieved a total remission rate of 40%, with a median duration of remission of 11.
1 months, and 63% of patients had a remission duration of more than 6 months.

The most common side effects of Rybrevant include skin rash, infusion-related reactions, skin infections around fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling of the calves or hands or face, mouth ulcers, cough, constipation, vomiting, and certain Changes in blood tests.

If the patient has symptoms of interstitial lung disease, Rybrevant should be discontinued, and if interstitial lung disease is diagnosed, Rybrevant should be permanently discontinued.

Patients taking Rybrevant should limit sun exposure during treatment and for two months after treatment.

Rybrevant may cause vision problems.

When administered to pregnant women, Rybrevant can also cause harm to the fetus; therefore, the pregnancy status of fertile women should be confirmed before treatment begins.

"The advancement of precision oncology is continuing to promote drug development, which can segment diseases like lung cancer through specific biomarkers into subgroups of patients suitable for targeted therapy.

" said Dr.
Julia Beaver, Director of the Department of Oncology, U.
S.
FDA Oncology Center of Excellence.
"Today's approval gives non-small cell lung cancer patients with EGFR exon 20 insertion mutations for the first time a targeted therapy option.

"Reference: [1] FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer.
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