“Submission is expected in the third quarter, with an approval decision anticipated in 2025.”

In context

“nstrating an objective response rate of 52% and median duration of response of 8.25 month. Detailed results will be presented at an upcoming medical congress. Following discussions with the FDA, we will be submitting to Teliso-V for accelerated approval as a monotherapy in patients with previously treated c-Met overexpressing EGFR wild-type non-squamous, non-small-cell lung cancer. This submission will be reviewed under FDA’s real-time oncology review program. Teliso-V has also received breakthrough therapy designation from the FDA. Our submission will be based on the results of our Phase 2 LUMINOSITY study, where Teliso-V demonstrated strong clinical benefits across key endpoints, including overall response rate, duration of response and overall survival, with a tolerable safety profile. Submission is expected in the third quarter, with an approval decision anticipated in 2025. The confirmatory Phase 3 study for this potential accelerated approval is currently ongoing. We continue to see encouraging data for ABBV-400, our next generation c-Met ADC, which uses a topo payload. Recall that we’ve advanced 400 in late-line colorectal cancer based on the deep responses and prolonged durability observed as a monotherapy in our Phase 1 trial. And we remain on track to begin a Phase 3 study later this year in third-line CRC. We’re also seeing encouraging signals of activity for this next-gen ADC in the non-small-cell lung cancer cohort from our Phase 1 study. The preliminary data will be presented at an upcoming medical meeting. And based on the emerging Phase 1 results, we plan to begin a Phase 2 program for 400 in lung cancer. In the area of hematologic oncology, we re”