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J&J’s bispecific lung cancer antibody nabs FDA breakthrough status

Potential treatment for patient group with no FDA-approved drugs


Johnson and Johnson has been awarded a breakthrough designation from the FDA for a bispecific antibody for lung cancer that combines MET and EGFR targeting in the same molecule.

JNJ-61186372 (JNJ-6372) is in trials as a treatment for adults with non-small cell lung cancer (NSCLC) EGFR exon 20 insertion mutations, a patient group with no FDA-approved drugs, according to the company.

The frequency of EGFR exon 20 insertions has previously been reported as being between 4% and 10% of all cases of EGFR-mutated NSCLC, and have also been seen in some other cancer types including a rare head and neck cancer known as sinonasal squamous cell carcinoma (SNSCC).

This type of mutation occurs in tumours that aren’t sensitive to treatment with first- and second-generation small-molecule EGFR inhibitors like AstraZeneca’s Iressa (gefitinib), Roche’s Tarceva (erlotinib) and Boehringer Ingelheim’s Giotrif (afatinib), and also seem to resist cancer immunotherapies such as checkpoint inhibitors.

Moreover, patients with this type of tumour also tend to have a worse prognosis than those with more common EGFR mutations so are currently treated with chemotherapy, which has a higher side effect burden.

At the moment it’s not clear whether third-generation EGFR inhibitors like AZ’s Tagrisso (osimertinib) possess improved efficacy, but more insight should come from an ongoing phase 2 trial of AZ’s drug due to read out in 2022.

Last year, Spectrum Pharmaceuticals reported some data for its third-generation drug poziotinib in EGFR exon 20 insertion mutation-positive NSCLC, but was denied a breakthrough designation from the FDA. It’s also due to generate results from a phase 2 trial in 2022.

The FDA has awarded the breakthrough status on the back of a 400-patient phase 1 study of JNJ-6372 in subjects with metastatic NSCLC that can’t be treated with surgery and has progressed after earlier standard treatment.

J&J’s study is testing JNJ-6372 on its own and also in combination with lazertinib, a third-generation EGFR inhibitor that the company’s pharma unit Janssen licensed from China’s Yuhan Corp in 2018 for $50m upfront and up to $1.25bn in potential development and commercial milestones.

Janssen developed JNJ-6372 in collaboration with Genmab, which is also its collaborator on blockbuster multiple myeloma therapy Darzalex (daratumumab) and follow-up HexaBody-CD38.

Article by
Phil Taylor

11th March 2020

From: Regulatory



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