“This year, data from a Phase 1 CRC study evaluating Temab-A in combination with bevacizumab could enable a Phase 3 study in an all-comers population.”

In context

“under review for accelerated approval of Teliso-V as a monotherapy in patients with previously treated c-Met overexpressing EGFR wild type non-squamous non-small cell lung cancer. The target for an approval decision is in the first-half of this year. This represents a segment of lung cancer with high unmet need where patients have limited options and tend to have a very poor prognosis. If approved, Teliso-V would be the first c-Met-directed ADC for the treatment of non-small cell lung cancer. We are also rapidly advancing our next-gen c-Met asset. A Phase 3 study evaluating ABBV-400, also known as Temab-A, was recently initiated in patients with c-Met overexpressed refractory metastatic colorectal cancer. Temab-A, as a monotherapy, is being compared against chemotherapy plus bevacizumab. This year, data from a Phase 1 CRC study evaluating Temab-A in combination with bevacizumab could enable a Phase 3 study in an all-comers population. Temab-A is also progressing well across lung programs. A Phase 2 study in EGFR wild-type non-small cell lung cancer is being planned, where Temab-A will be evaluated with a PD-1 inhibitor as a frontline combination therapy. In the EGFR mutant segment, results from the ongoing Phase 1 study could enable Temab-A dose optimization studies as a monotherapy in the second line setting and in combination with osimertinib in the first line setting. In gastroesophageal cancer, a Phase 2 trial was recently started evaluating Temab-A in combination with chemotherapy and a PD-1 inhibitor in frontline patients. We are also excited about ABBV-706, an ADC that utilizes the same Topo warhead and linker technology as Temab-A, but with an antibody that targets SEZ6. Encouraging data in small lung cancer, s”