How effective is Exkivity (mobocertinib) for NSCLC?

Note: On October 2, 2023 Takeda Pharmaceuticals announced the voluntary withdrawal of Exkivity from the U.S and global markets. Exkivity did not meet the primary endpoint of the Phase 3 EXCLAIM-2 confirmatory trial and did not meet the requirements of the Accelerated Approval granted by the FDA for the treatment of NSCLC.

Key Points

• The effectiveness of Exkivity was determined by looking at the overall response rate (ORR) and the duration of response (DoR) to treatment.
• In clinical studies, 32 of 114 patients (28%) with non-small cell lung cancer (NSCLC) had a partial response to Exkivity treatment. In these patients, the response to treatment lasted for about 17.5 months.
• Close to 59% of patients who responded had a response that lasted at least 6 months. Median overall survival was 24 months (2 years).

Exkivity study results

In Sept., 2021, the FDA granted accelerated approval to Exkivity (mobocertinib) based on a clinical research study known as Study 101. This study included 114 patients with non-small cell lung cancer (NSCLC) that had spread to other parts of the body and could not be removed by surgery. These patients had EGFR exon 20 insertion mutations in their lung cancer, as determined by a special test.

Patients were on or had previously received a chemotherapy treatment that contained platinum, but their disease had worsened. In the study, the participants received a 160 mg oral dose of Exkivity once daily until their lung cancer worsened or they had side effects they could not tolerate.

The effectiveness of Exkivity was determined by looking at the overall response rate (ORR) and the duration of response (DoR). The ORR looks at how many people using Exkivity saw a tumor response like shrinkage. The DoR measures how long the response lasted.

Overall, about 28% of the people (32/114) had a partial response to Exkivity treatment and the response lasted for about 17.5 months. Close to 59% of patients who responded (19/32) had a response that lasted at least 6 months. The median overall survival was 24 months (2 years). Median means that half the people lived longer than 24 months, and the other half lived less than 24 months.

On October 2, 2023 Takeda Pharmaceuticals announced the voluntary withdrawal of Exkivity from the U.S and global markets as Accelerated Approval confirmatory studies did not meet the required endpoints.

Related Questions

• How do Exkivity and Rybrevant compare for NSCLC?
• Is small cell or non-small cell lung cancer worse?
• Is non-small cell lung cancer hereditary?

Exkivity common side effects

The most common side effects (>20%) reported in Study 101 for Exkivity were:

• Diarrhea
• Rash
• Mouth sores
• Vomiting
• Decreased appetite
• Infection of skin around nails
• Nausea
• Muscle or bone pain
• Dry skin
• Feeling Tired

Exkivity labeling carries a Boxed Warning for QTc prolongation and Torsades de Pointes (types of dangerous heart rhythms), warnings for certain types of lung or heart toxicity, and diarrhea.

What is Exkivity?

Exkivity (mobocertinib) is an oral kinase inhibitor formerly approved for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations that has progressed on or after platinum-based chemotherapy. It was a first-in-class oral therapy specifically designed to target EGFR Exon 20 insertion mutations.

When available, Exkivity came as a 40 mg capsule. The recommended dose was 160 mg (4 capsules) orally once daily, with or without food.

This is not all the information you need to know about Exkivity (mobocertinib) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss any questions you have with your doctor or other health care provider.