Date: 18-Sep-2021

J&J Takedas Growth Plan Bears Fruit With FDA Nod For Niche Lung Cancer Drug Exkivity

Takeda has been hoping its Wave 1 pipeline of medicines can drive near-term growth, but the group has been through a rough patch lately. With an FDA go-ahead for a niche lung cancer drug, the Japanese pharma has finally scored a regulatory win and has its chance to challenge Johnson & Johnson.

The FDA granted conditional approval to Takeda’s Exkivity, or mobocertinib, for treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations after progression on or after platinum-based chemotherapy, the company said Wednesday.

 

 

EGFR exon 20 disease makes up 1% to 2% of all NSCLC cases, or about 2,000 to 4,000 patients per year in the U.S., Dion Warren, Takeda’s head of the company's U.S. oncology business unit, said in an interview ahead of the approval. Takeda has projected peak sales of $300 million to $600 million for the medicine.

 

EGFR exon 20-mutated NSCLC patients typically respond poorly to other EGFR inhibitors such as AstraZeneca’s Tagrisso as those drugs aren’t specifically designed to target this disease subtype. It was only in May that Johnson & Johnson’s bispecific antibody Rybrevant became the first FDA-approved drug for the patient group.

 

RELATED: Johnson & Johnson snares FDA nod for first exon 20-targeted drug in EGFR lung cancer

 

For a rare cancer type that didn’t have effective targeted therapies until recently, Takeda’s initial marketing strategy focuses on driving accurate diagnosis and physician education, Warren said. Diagnosis can be a challenge, and increasing awareness for this patient population takes time, he acknowledged. Exkivity represents Takeda’s second targeted lung cancer drug, coming after Alunbrig for ALK-positive disease. Thanks to that prior launch, the company can at least spare the trouble of building a physician network from scratch.

 

 

Alongside the Exkivity nod, the FDA has simultaneously approved an NGS companion diagnostic by Thermo Fisher, which Takeda said can enable more accurate diagnoses than PCR testing.

 

 

Besides Takeda's efforts to find patients, the company's new drug also needs to compete with J&J's Rybrevant. By looking at early tumor shrinkage data, the Takeda drug appears to be the underdog.

 

 

In a phase 1/2 trial, Exkivity triggered a response in 28% of post-chemo EGFR exon 20 insertion patients by analysis of an independent data review committee, or 35% by investigator evaluation, according to an update in February. By comparison, Rybrevant has reported a response rate of 40% in its own early-stage trial.