In a first, Janssen submits lung cancer bispecific hopeful amivantamab to the FDA

Janssen has sent off its mutation-specific non-small cell lung cancer drug amivantamab to the FDA.

Janssen is looking for a 2021 approval in patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

This is the first-ever attempt at an approval for a treatment in this patient population, with Janssen also setting up a so-called expanded access program so people could potentially use the drug while the FDA is reviewing it.

The drug works as a fully human EGFR and mesenchymal epithelial transition factor bispecific antibody with immune-cell-directing activity. It has already been given an FDA breakthrough tag.

The idea is that while other cancer drugs, such as tyrosine kinase inhibitors (TKIs), hit the receptor from inside the cell, antibodies like amivantamab attack it from outside the cell, so they aren’t vulnerable to resistance-causing mutations.

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Although there are a number of drugs on the market for NSCLC cancer, such as Tagrisso, Keytruda and Xalkori, the disease is still a major killer with a poor prognosis, with many drugs focusing in on particular mutations.

Data for the submission come from a phase 1 test, where investigators assessed its efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version (known as RECIST), as well as the clinical benefit rate, duration of response and progression-free survival (PFS).

The data showed an ORR of 36% in all patients and 41% in patients previously treated with chemo. The median duration of response for all evaluable patients was 10 months and seven months for patients previously treated with chemo, and PFS was 8.3 months for all patients and 8.6 months patients previously treated with chemo.

The FDA will now decide whether to accept the drug for review.

The drug is also being tested in combo with lazertinib, a TKI Janssen licensed from South Korea’s Yuhan in 2018.