KEY TAKEAWAYS
- The phase 1/2 trial evaluated the safety and efficacy of I-DXd in SCLC patients.
- I-DXd showed lasting effectiveness and tolerable side effects in a heavily treated SCLC subset.
This analysis focused on the small cell lung cancer (SCLC) patient group from the first part of the phase 1/2 trial. It included heavily pretreated individuals with advanced solid tumors, unselected for B7-H3 expression levels. Safety and efficacy evaluations considered the range of Ifinatamab Deruxtecan (I-DXd) dosages between 4.8 and 16.0 mg/kg administered to SCLC patients (pts).
As of January 31, 2023, 21 SCLC pts were assessed for safety, response, progression-free survival (PFS), and overall survival (OS). Treatment was still active for 2 of these pts. On average, pts had undergone two rounds of previous treatments, mostly involving platinum-based chemotherapy and immunotherapy. The safety profile aligns with prior findings. Out of the cohort, 11 pts exhibited a confirmed objective response (52%), including one complete and 10 partial responses, with the median duration of response being 5.9 months (95% CI, 2.8 – 7.5). The median PFS and OS were 5.8 and 9.9 months, respectively. A subset of 16 pts was available for B7-H3 expression analysis (as of June 30, 2022). All these pts showed moderate to high levels of B7-H3 expression. However, no clear patterns linked B7-H3 expression levels with response outcomes.
In this cohort of heavily treated SCLC pts, I-DXd showed strong and durable effectiveness. It was well-tolerated with controllable side effects. A phase 2 trial is ongoing, focusing solely on pts at the extensive stage of SCLC and in their second or third lines of treatment.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/956
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05280470
Johnson, M., Awad, M., Koyama, T., Gutierrez, M., Falchook, G.S., Piha-Paul, S.A., Doi, T., Satoh, T., Okamoto, N., Singh, J., Yoshizuka, N., Qian, M., Qian, X., Tran, B.P., Dosunmu, O., Mucha, R., Windish, H., Patel, M.R. Ifinatamab Deruxtecan (I-DXd; DS-7300) in Patients with Refractory SCLC: A Subgroup Analysis of a Phase 1/2 Study.
