Merck has been granted Breakthrough Therapy designation by the US FDA for its ADC, sacituzumab tirumotecan (sac-TMT)
The biopharmaceutical is suitable for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer who have EGFR mutations.
Eligible patients will have exhibited disease progression after treatment with both tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy.
More about Sac-TMT
Sacituzumab tirumotecan is an antibody-drug conjugate that Merck is currently developing in collaboration with Kelun Biotech.
It's a TROP2-directed ADC consisting of a TROP-2 monoclonal antibody (sacituzumab), a cytotoxic payload and an irreversible linker.
The biologic received FDA Breakthrough Therapy designation because of the data collectd from a Phase II expansion cohort of a Phase I/II study, which evaluated the role of Sac-TMT in patients with EGFR-mutated NSCLC.
This data was presented at the 2023 American Society of Clinical Oncology Annual Meeting.
“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 Dr. Scot Ebbinghaus, VP of global clinical development at Merck Research Laboratories.
“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.”
Further research into sac-TMT's potential
Currently, Merck is determining the efficacy of sac-TMT in a range of contexts; this includes as a monotherapy and in combination with Keytruda (pembrolizumab).
There are currently 10 ongoing Phase III studies across a range of solid tumour indications.
They are the only Phase III trials to evaluate a TROP-2 targeted ADC in this type of cancer.