FDA Grants Breakthrough Therapy Designation to Merck’s Sacituzumab Tirumotecan for Metastatic Nonsquamous Non-Small Cell Lung Cancer

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The FDA has granted Breakthrough Therapy Designation to Merck’s sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) for the treatment of advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations (exon 19 deletion or exon 21 L858R). According to the company, the decision was supported by promising data from a Phase II study and earlier trials— presented at the 2023 American Society of Clinical Oncology Annual Meeting—and data from two parts of a Phase II study evaluating sac-TMT in patients with EGFR-mutated NSCLC who were treated with at least two lines of prior therapy.¹

“This designation by the FDA highlights the importance of developing novel therapeutic options for patients living with EGFR-mutated nonsquamous non-small cell lung cancer,” said Scot Ebbinghaus, VP, global clinical development, Merck Research Laboratories, in a press release. “We believe ADCs are an important modality in the treatment of cancer and are rapidly advancing the clinical development of sacituzumab tirumotecan, with the goal of meaningfully improving upon current standards of care in certain cancers.”

Merck is currently working to advance the global clinical development program evaluating sac-TMT as a monotherapy and in combination with Keytruda(pembrolizumab), with 10 ongoing Phase III studies across various solid tumors. This includes TroFuse-004, which is evaluating sac-TMT versus chemotherapy in patients with previously treated NSCLC with EGFR mutations or other genomic alterations, and TroFuse-009, which is evaluating sac-TMT versus doublet chemotherapy in certain patients with previously treated EGFR-mutated NSCLC.

According to the American Cancer Society, lung cancer is the leading cause of cancer mortality in the United States, accounting for one in every five cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. Anywhere from 80% to 85% of all lung cancers are NSCLC, making it the most common form of the disease. By the end of the year, it is estimated that there will be 234,580 new cases of lung cancer and approximately 125,070 deaths.

While lung cancer mainly occurs in people over 65 years of age, it can be diagnosed in patients under 45 years of age, with a median diagnosis age of 70 years. Black men are about 12% more likely to develop lung cancer than white men, with the rate being 16% lower in Black women than in white women. Although women have lower rates than men, data in recent years has shown that the lung cancer rate has been dropping among men over the past few decades, but only for about the past decade in women.²

According to Merck, Sac-TMT recently received its first marketing authorization in China from the National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies, based on results from the Phase III OptiTROP-Breast01 study. Developed by Kelun-Biotech, Merck has been granted exclusive rights to develop, manufacture, and commercialize sac-TMT in all territories outside of Greater China.¹

References

1. FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations. Merck. December 3, 2024. Accessed December 3, 2024. https://www.merck.com/news/fda-grants-breakthrough-therapy-designation-to-sacituzumab-tirumotecan-sac-tmt-for-the-treatment-of-certain-patients-with-previously-treated-advanced-or-metastatic-nonsquamous-non-small-cell-lung-ca/

2. Key Statistics for Lung Cancer. American Cancer Society. Accessed December 3, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html