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ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC)
Abstract   Peer reviewed

ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC)

Lauren Averett Byers, Byoung Chul Cho, Alissa Jamie Cooper, Anne C. Chiang, Ji-Youn Han, Daniel Morgensztern, Muhammad Furqan, Afshin Dowlati, Jair Bar, Joo-Hang Kim, …
Journal of clinical oncology, Vol.44(16_suppl), pp.8008-8008
06/01/2026
DOI: 10.1200/JCO.2026.44.16_suppl.8008

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Abstract

8008Background: SCLC is an aggressive cancer with poor prognosis and limited treatment options. Seizure-related 6 homolog (SEZ6) is overexpressed in SCLC. ABBV-706 is a SEZ6-targeting antibody-drug conjugate with topoisomerase 1-inhibitor payload. Here we report updated data from a phase 1 study (NCT05599984) evaluating ABBV-706 in patients (pts) with R/R SCLC as monotherapy or in combination with budigalimab (Budi), an anti-PD-1 immune checkpoint inhibitor (CPI). Methods: The study enrolled pts ≥18 years old with R/R SCLC and Eastern Cooperative Oncology Group performance score ≤1. Pts received either ABBV-706 monotherapy every 3 weeks (Q3W), or in combination with 375 mg Budi Q3W. Results: As of Sept. 27, 2025, 124 pts received ABBV-706 monotherapy. Of these, 41 received the recommended phase 3 dose (1.8 mg/kg), with 17 receiving ABBV-706 as a second-line (2L) therapy. Overall, median age was 64 years, and most pts (65%) received at least 2L of prior treatment. The safety profile was comparable with previously reported data. Median follow-up (mFU) was 16.2 months, and median overall survival (mOS) overall (N=124) and among pts receiving 1.8 mg/kg as 2L (n=17) was 11.3 and 14.3 months, respectively. The 15-month OS estimates for the same cohorts were 40% and 50%, respectively. As of Sept. 27, 2025, 11 pts received ABBV-706 (1.8 mg/kg Q3W) + Budi as 2L treatment. Median age was 68 years. No new safety signals were detected as compared to monotherapy, and there were no reports of pneumonitis. Treatment-related adverse events (TRAEs) occurred in 91% of pts, most commonly gastrointestinal (64%) and hematological (64%). TRAEs grade ≥3 occurred in 46% of pts, with anemia (27%) and neutrophil count decreased (18%) being most common. TRAEs led to treatment discontinuation, interruption, or dose reduction in 0%, 64%, and 36% of pts, respectively. No treatment-related deaths were reported. mFU was 9.1 months. Detailed efficacy endpoints are shown in the Table. Conclusions: ABBV-706 monotherapy shows promising OS benefit in a heavily pretreated pt population with R/R SCLC and is combinable with a CPI. Clinical trial information: NCT05599984. Efficacy of ABBV-706 in R/R SCLC.MonotherapyTotal(N=124)Monotherapy1.8 mg/kg (n=41)Monotherapy1.8 mg/kg as 2L(n=17)ABBV-706 1.8 mg/kg + Budi(n=11)Best overall response,a,b n (%)Complete response3 (2)3 (7)2 (12)0Partial responsec64 (52)20 (50)12 (71)6 (55)Stable disease46 (37)16 (39)2 (12)3 (27)Progressive disease6 (5)1 (2)1 (6)1 (9)NE/not assessed5 (4)1 (2)01 (9)Objective response ratea (%)52568255Median duration of response, months5.3d5.9e6.6f6.7gMedian progression-free survival, months5.46.46.88.1mOS, months11.312.414.3NEOS estimate at 15 months, %404450NEaConfirmed by investigator per RECIST v1.1.bPercentages may exceed 100% due to rounding.cIncludes 2 pts with unconfirmed partial response and ongoing treatment.dn=65.en=23.fn=14.gn=6.

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