ABBV-706: Durable Response & Tolerable Yields in Relapsed SCLC
ABBV-706 Clinical Trial Data Summary:
Here’s a breakdown of the key findings from the provided text regarding ABBV-706:
Efficacy:
DOR (Duration of Response):
Overall: 6.9 months (95% CI, 3.0 months-NE)
Second-line: 6.2 months (95% CI,2.8-NE)
Chemo-free interval < 30 days: 4.4 months (2.5mg/kg cohort), 5.2 months (2.5mg/kg cohort), 5.0 months (2.5mg/kg cohort)
PFS (Progression-Free Survival):
Overall: 5.7 months (95% CI, 4.9-7.0)
Second-line: 6.8 months (95% CI, 4.4-8.4)
chemo-free interval < 30 days: 5.7 months (95% CI, 3.9-7.5)
1.8 mg/kg cohort: 6.8 months (95% CI, 4.0-8.2) vs 2.5 mg/kg cohort: 5.6 months (95% CI, 4.4-7.0)
Second-line (1.8 vs 2.5 mg/kg): 7.5 months (95% CI, 4.0-8.4) vs 5.4 months (95% CI,2.8-NE)
Chemo-free interval < 30 days (1.8 vs 2.5 mg/kg): 7.0 months (95% CI, 2.0-NE) vs 4.4 months (95% CI, 2.2-7.0)
OS (Overall Survival): Data immature, 9-month OS rate of 0.6% (95% CI, 0.5%-0.7%).
ORR (Objective Response Rate): Similar too the first-line standard of care (platinum-etoposide-checkpoint inhibitor).
Key Efficacy takeaway: ABBV-706 appears to have efficacy comparable to the standard first-line treatment, even when used in later lines of therapy. The 1.8 mg/kg dose showed a trend towards improved PFS compared to the 2.5 mg/kg dose.
Safety:
TRAEs (Treatment-Related Adverse events):
Overall (Total Population): 90% any-grade, 63% Grade 3+, 14% Serious AEs
1.8 mg/kg: 85% any-grade, 49% Grade 3+, 17% Serious AEs
2.5 mg/kg: 95% any-grade, 77% Grade 3+, 10% Serious AEs
Dose Interruptions/Reductions/Discontinuations: Substantially higher with the 2.5 mg/kg dose.
Treatment Duration (Median): 5.8 months (95% CI, 0.7-11.3)
Relative Dose Intensity: 92% 99% in 1.8mg/kg arm, 85% in 2.5mg/kg arm.
* Hematological AEs: Dose-dependent. Common in the 1.8 mg/kg arm included anemia, neutropenia, thrombocytopenia, and leukopenia.Key Safety Takeaway: The 1.8 mg/kg dose of ABBV-706 demonstrated a more favorable safety profile with fewer and less severe adverse events, leading to better dose intensity and treatment duration compared to the 2.5 mg/kg dose.Important Note: “NE” in the confidence intervals likely stands for “Not Estimable,” indicating the data was insufficient to calculate a reliable upper bound.