604 Magrolimab + docetaxel in previously treated patients with metastatic non-small cell lung cancer (NSCLC)

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Background Patients with metastatic NSCLC who progress after chemotherapy ± immune checkpoint inhibitors (ICIs) are limited to single-agent chemotherapy (eg, docetaxel). New treatments are needed in this setting. Magrolimab is a cluster of differentiation 47 (CD47)–targeting antibody that blocks antiphagocytic signals on tumor cells. Chemotherapy may synergize with magrolimab by enhancing prophagocytic signals. This phase 2, multicohort study (NCT04827576) evaluated magrolimab + docetaxel in patients with advanced solid tumors. We present primary results from the metastatic NSCLC cohort. Methods Patients treated with ≥1 prior line of therapy (LOT) for locally advanced or metastatic NSCLC were initially enrolled in a safety run-in (SRI) cohort (n=2) for dose-limiting toxicity (DLT) assessment. Patients with 1–2 prior LOTs (including chemotherapy and ICIs) for metastatic NSCLC enrolled in a subsequent phase 2 cohort (n=29). Patients received magrolimab (1 mg/kg on day 1, then 30 mg/kg per week, then 60 mg/kg every 3 weeks starting in cycle 3) and docetaxel (75 mg/m2 on day 1 of each cycle) intravenously in 21-day cycles. Primary endpoints were adverse event (AE) incidence and objective response rate (ORR). Secondary endpoints included progression-free survival, duration of response, and overall survival. Results Thirty-one patients with metastatic NSCLC were treated across the SRI and phase 2 cohorts. The median age was 65 years (range, 36–82). Most patients had ≥2 prior LOTs (58.1%), Eastern Cooperative Oncology Group performance status of 0–1 (93.5%), nonsquamous or unknown histology (83.9%), and currently/formerly smoked (80.6%). The ORR was 19.4%. Other efficacy outcomes are shown in table 1. There were no DLTs in the SRI. The most common grade ≥3 treatment-emergent AEs (TEAEs) were neutropenia (48.4%), anemia (22.6%), leukopenia (19.4%), and asthenia (16.1%). TEAEs leading to study drug discontinuation occurred in 6 (19.4%) patients. TEAEs leading to death occurred in 4 patients; none of these fatal TEAEs were treatment-related (table 1). No new safety signals were identified for magrolimab. Conclusions These data support potential activity of anti-CD47 in combination with docetaxel in NSCLC. Acknowledgements Medical writing was provided by Jan Nagel, PhD, of Ashfield MedComms, an Inizio company. All medical writing and editorial support was funded by Gilead Sciences. Trial Registration ClinicalTrials. gov; NCT04827576. Ethics Approval The protocol and proposed informed consent form were reviewed and approved by all relevant Institutional Review Boards, Independent Ethics Committees and/or Research Ethics Boards prior to study commencement. There is no number provided as we did not receive one Participants gave informed consent to participate in the study before taking part.

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