The Accelerated Approval of Telisotuzumab Vedotin for NSCLC: Dr. Singhi Shares What Clinicians Should Know

Eric Singhi, MD, of the University of Texas MD Anderson Cancer Center, joined Lung Cancers Today to discuss the FDA’s accelerated approval of telisotuzumab vedotin for certain adults with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) who have received a prior systemic therapy.

The accelerated approval is specifically for patients with high c-Met protein overexpression, defined as at least 50% of tumor cells with strong staining, as determined by an FDA-approved test.

“It’s exciting to have this option for patients,” Dr. Singhi said.

In tandem with the approval of the antibody-drug conjugate, the FDA also approved the VENTANA MET (SP44) RxDx Assay as a companion diagnostic test to aid in detecting c-Met protein overexpression in patients with nonsquamous NSCLC.

Dr. Singhi said this makes it critical for clinicians and multidisciplinary teams to recognize that this is a “new biomarker that we need to be checking for and that does have an FDA approval.”

Although there isn’t a one-size-fits-all approach on how to integrate this testing into the workflow, it’s a critical step.

“There isn’t necessarily reflex testing that everyone may be following, but make sure when you’re thinking about different options—when you’re thinking about how to sequence therapies for your patients with non–small cell lung cancer—remember that this is a biomarker that we do need to be checking to potentially offer an FDA-approved option for patients,” Dr. Singhi said.

The efficacy of the therapy was evaluated in the multicenter, open-label LUMINOSITY study, which included 84 patients who had nonsquamous NSCLC with high c-Met protein overexpression and had received prior systemic therapy.

“Importantly, they were EGFR wild-type,” Dr. Singhi said. “What we saw was that these patients, despite being pretreated, had an objective response rate close to 35%.”

The study showed the median duration of response was 7.2 months (95% CI, 4.2-12), Dr. Singhi said, noting that he looks forward to “offering this new regimen to patients to provide, hopefully, more time with their loved ones and their family.”

The most common adverse reactions, occurring in at least 20% of a pooled safety population, included peripheral neuropathy, fatigue, decreased appetite, and peripheral edema, Dr. Singhi said, noting that it’s important for clinicians to ensure they’re “counseling patients about these potential toxicities.”