Takeda Announces Failure of Phase III EXCLAIM-2 Trial for Mobocertinib in First-Line EGFR Exon20 Insertion-Positive NSCLC

On July 27, Takeda announced the termination of the Phase III EXCLAIM-2 trial evaluating Exkivity (Mobocertinib), an oral EGFR Exon20 inhibitor, as a first-line treatment for non-small cell lung cancer (NSCLC) with EGFR Exon20 insertion mutations, due to lack of efficacy, while releasing its Q1 financial results for fiscal year 2023 (April-June).

Exkivity once won FDA accelerated approval based on data from a small-scale Phase I/II clinical trial (NCT0271611) for the treatment of adult patients with locally advanced or metastatic NSCLC who carry EGFR exon 20 insertion mutations and whose disease has progressed after receiving platinum-based chemotherapy. It became the first FDA-approved oral EGFR Exon20 inhibitor. On January 11 this year, the drug was approved for marketing in China.

Johnson & Johnson's EGFR/c-Met bispecific antibody Rybrevant (amivantamab) received FDA accelerated approval earlier than Exkivity for the same indication. However, in the recent Phase III PAPILLON study on first-line treatment of EGFR Exon20 insertion mutation NSCLC, Rybrevant demonstrated a statistically significant and clinically meaningful improvement in PFS for patients receiving Rybrevant + chemotherapy compared to chemotherapy alone.

Takeda also disclosed that another candidate drug, enzyme replacement therapy TAK-611, did not meet the primary and secondary endpoints in the Phase II trial for the treatment of metachromatic leukodystrophy (MLD).

The results of Takeda’s Phase IIb study on its selective orexin receptor 2 agonist TAK-994 for the treatment of Type 1 Narcolepsy (NT1) have been published in NEJM. The treatment showed significant efficacy but the trial was terminated early due to hepatotoxicity. The drug had previously received Breakthrough Therapy Designation (BTD) from the FDA and CDE for the treatment of NT1.

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