Contributions
Abstract: S771
Type: Oral Presentation
Presentation during EHA22: On Sunday, June 25, 2017 from 08:30 - 08:45
Location: Hall A
Background
Venetoclax monotherapy in patients (pts) with relapsed/refractory CLL harboring deletion 17p (del17p) resulted in an ORR of 79% with a CR rate of 7% as determined by an independent review committee at the initial analysis of the pivotal M13-982 trial (n=107). Subsequently, 51 additional pts were enrolled in a safety expansion cohort.
Aims
To present results from the full trial, including minimal residual disease (MRD) status by both flow cytometry and next generation sequencing (NGS).
Methods
Pts received venetoclax 400 mg daily after initial standard ramp-up until PD or discontinuation due to other reasons. CT scan was mandatory at week 36, after which disease assessment was by clinical evaluation. MRD assessment was performed beginning with the first clinical assessment of CR or PR with nodes <2 cm and then every 12 weeks until MRD negativity (defined at 10−4 sensitivity). MRD was assessed by NGS and multicolor flow cytometry and the best response was reported. Data cutoff date was 10 June 2016.
Results
Pts (N=158) had a median age of 67 (range, 29–85) years; a median of 2 prior therapies (range, 0–10); 32% were fludarabine refractory; 11% had previously received a B-cell receptor signaling inhibitor (BCRi); 48% had nodes ≥5 cm; and 78% had unmutated IGHV. The median duration of venetoclax therapy was 16.7 (range 0–34.4) months. Primary reasons for discontinuation (50.6% of pts) were PD (31.0%), adverse events (AEs) (12.6%), withdrawal of consent (2.5%), stem cell transplant (2.5%), and other (1.9%).
Conclusion
Venetoclax monotherapy resulted in a high response rate that was durable in this high-risk population, including among pts who had previously received a BCR inhibitor. MRD negativity by either flow cytometry or NGS correlated with outstanding outcomes.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Relapse, Refractory, Minimal residual disease (MRD), Chronic Lymphocytic Leukemia
Abstract: S771
Type: Oral Presentation
Presentation during EHA22: On Sunday, June 25, 2017 from 08:30 - 08:45
Location: Hall A
Background
Venetoclax monotherapy in patients (pts) with relapsed/refractory CLL harboring deletion 17p (del17p) resulted in an ORR of 79% with a CR rate of 7% as determined by an independent review committee at the initial analysis of the pivotal M13-982 trial (n=107). Subsequently, 51 additional pts were enrolled in a safety expansion cohort.
Aims
To present results from the full trial, including minimal residual disease (MRD) status by both flow cytometry and next generation sequencing (NGS).
Methods
Pts received venetoclax 400 mg daily after initial standard ramp-up until PD or discontinuation due to other reasons. CT scan was mandatory at week 36, after which disease assessment was by clinical evaluation. MRD assessment was performed beginning with the first clinical assessment of CR or PR with nodes <2 cm and then every 12 weeks until MRD negativity (defined at 10−4 sensitivity). MRD was assessed by NGS and multicolor flow cytometry and the best response was reported. Data cutoff date was 10 June 2016.
Results
Pts (N=158) had a median age of 67 (range, 29–85) years; a median of 2 prior therapies (range, 0–10); 32% were fludarabine refractory; 11% had previously received a B-cell receptor signaling inhibitor (BCRi); 48% had nodes ≥5 cm; and 78% had unmutated IGHV. The median duration of venetoclax therapy was 16.7 (range 0–34.4) months. Primary reasons for discontinuation (50.6% of pts) were PD (31.0%), adverse events (AEs) (12.6%), withdrawal of consent (2.5%), stem cell transplant (2.5%), and other (1.9%).
Conclusion
Venetoclax monotherapy resulted in a high response rate that was durable in this high-risk population, including among pts who had previously received a BCR inhibitor. MRD negativity by either flow cytometry or NGS correlated with outstanding outcomes.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Relapse, Refractory, Minimal residual disease (MRD), Chronic Lymphocytic Leukemia