Efficacy

Enhertu (fam-trastuzumab deruxtecan-nxki) Efficacy in Lung Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is a targeted therapy approved for the treatment of adults with unresectable or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation known as HER2 (human epidermal growth factor receptor 2) overexpression. Clinical trials have shown that Enhertu can significantly improve the outcomes in patients with this type of lung cancer. In a pivotal phase 2 trial, patients treated with Enhertu demonstrated a notable response rate, indicating a reduction in tumor size. The duration of response and progression-free survival were also observed to be promising, providing a new avenue of hope for patients with HER2-mutant or HER2-overexpressing NSCLC.

It is important to note that Enhertu's efficacy is specifically linked to the presence of the HER2 mutation. As such, patients must undergo diagnostic testing to confirm HER2 overexpression or mutation before starting treatment with Enhertu. This personalized approach to cancer treatment ensures that the therapy is used in the population most likely to benefit from its mechanism of action, which combines antibody-drug conjugate technology with a potent cytotoxic agent.

Exkivity (mobocertinib) Efficacy in Lung Cancer

Exkivity (mobocertinib) is an oral medication approved for the treatment of adult patients with metastatic NSCLC harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. This kinase inhibitor has shown significant efficacy in shrinking tumors in patients with this specific genetic alteration. The approval of Exkivity was based on the results of a clinical trial that demonstrated a considerable response rate in patients with EGFR exon 20 insertion-positive NSCLC. The responses were durable, and the median progression-free survival indicated a meaningful clinical benefit for patients with this challenging-to-treat form of lung cancer.

Exkivity's approval underscores the importance of genetic testing in the management of NSCLC. The presence of EGFR exon 20 insertion mutations can be identified through molecular testing, which is critical for determining the appropriate treatment course. By targeting a specific mutation within the cancer cells, Exkivity offers a personalized treatment option that can lead to better outcomes for patients with this particular molecular profile of lung cancer.