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AACR 2017 | Poster CT132/13 – A phase IIb randomized study (SADAL) of selinexor achieves durable responses in GCB & Non-GCB subtypes of relapsed/refractory Diffuse Large B-Cell Lymphoma

Apr 13, 2017

At the American Association for Cancer Research(AACR) annual meeting in Washington, DC, USA, on Tuesday 4 thApril, a poster session titled “ Phase I-III Clinical Trials and Pediatric Clinical Trials” took place.

One of the posters on display ( CT132 / 13) was titled “A Phase 2b randomized study of selinexor in patients with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) demonstrates durable responses in both GCB & Non-GCB subtypes” by Marie Maerevoetfrom Institut Jules Bordet, Brussels, Belgium, and colleagues.

In this phase IIb trial ( SADAL), R/R DLBCL patients were randomized to receive 60mg or 100mg of selinexor twice weekly (8 doses) per 28-day cycle. Additionally, patients were grouped by the subtype of their DLBCL (GCB or non-GCB). The primary objectives are to determine the ORR, and safety of 60mg compared to 100mg doses.

Key Highlights:

  • In total, 67 pts enrolled (n = 33 at 60mg; n = 34 at 100mg) enrolled
  • The most common related AEs across both dosing groups (grade 1/2) = nausea (46%), anorexia (43%), vomiting (36%), and fatigue (34%)
  • Frequent grade 3/4 AEs = thrombocytopenia (39%), fatigue (18%), neutropenia (16%), and anemia (10%)
    • These were managed with dose interruption/reduction, platelet stimulators, and/or standard supportive care
  • Grade 3/4 fatigue was higher in 100mg arm (13%) vsthe 60mg arm (4%)
  • Grade 3/4 thrombocytopenia was higher in 100mg arm (22%) vsthe 60mg arm (16%)
  • Among 65 evaluable pts, ORR = 21.5%
  • Responders had a median of 3 prior treatment regimens
  • CR = 12.3% (n = 8); PR = 9.2% (n = 6)
  • Remain on treatment = 9 responders, including 7 CRs
  • Median time on study for CR is 8.8+ months
  • ORR by subtype: GCB = 23.5%; non-GCB = 19.3%
  • ORR was higher in 60mg arm (26.4%) vs100 mg arm (16.1%), potentially because of better tolerability and less time without drug exposure

In conclusion, monotherapy with selinexor demonstrates anti-cancer activity in R/R DLBCL patients including those with GCB subtype. Dosing at 60mg twice weekly was tolerated better than 100mg twice weekly, with less interruptions to dosing due to toxicity and a trend towards higher response rates. Moreover, durable objective responses were achieved with selinexor, which the authors hypothesize may be “associated with clinical benefit.”

  1. Maerevoet M. et al.A Phase 2b randomized study of selinexor in patients with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) demonstrates durable responses in both GCB & Non-GCB subtypes [Poster]. In: Proceedings of the 107th Annual Meetingof the American Association for Cancer Research; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; 2017. Poster nr [ CT132 / 13].