Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial.

• DOI: 10.1200/jco.2021.39.15_suppl.7512
• Publication Date: 2021-06-02T14:31:50Z
• Authors: Catherine S. Magi...; Pau Abrisqueta; Eva Gonzalez-Barca; Carlos Panizo; Jose Maria Arguin...; Fiona Miall; Mariana Bastos-Or...; Armando Lopez-Gui...; Lalita Banerjee; Andrew McMillan; Jamie Hirata; Lisa Musick; Sourish Saha; Brandon Croft; Erlene Kuizon Sey...
• Keywords: Tolerability; Refractory (planetary science); International Prognostic Index

7512 Background: The combination of Pola-R-Len may enhance anti-tumor response in R/R DLBCL. We report the primary analysis DLBCL cohort a Phase 1b/2 study (GO29834; NCT02600897). Methods: Pts received induction with 6 x 28-Day (D) cycles (C) of: Pola 1.8mg/kg intravenous (IV; C1−6: D1); R 375mg/m 2 IV (C1−6: D1) and oral Len 10–20mg (dose escalation) or recommended dose (RP2D) daily on D1–21. at end (EOI) months (mo) consolidation (D1 every mo) 10mg (D1–21 monthly). Primary endpoints were safety/tolerability positron emission tomography (PET)-complete (CR) rate EOI by independent review committee (IRC) modified Lugano criteria. Results: At (Sep 08, 2020), 57 pts enrolled. Median age was 71 years (range 28–92); male (67%); Ann Arbor Stage III–IV (86%); International Prognostic Index 3–5 (60%); median prior therapies; bone marrow transplant (11%); CAR-T therapy (5%); refractory (49%) to last (65%). Grade 3–4 adverse events (AEs) experienced 75% pts, most commonly, neutropenia (58%), thrombocytopenia (14%), infections (14%) anemia (11%). AEs led reduction 25% interruption 63% pts. One 5 treatment-related AE (neutropenic sepsis) reported. In total, 49 treated RP2D (Pola + 20mg). IRC PET-CR 29% (Table). A best overall (BOR) assessed investigator (INV) seen 36/49 (74%) 17/49 (35%) achieving CR; these, 14/17 (82%) remain remission cutoff date. duration (DOR) 8.1 mo (95% confidence interval [CI]: 4.7–not evaluable [NE]). After follow-up 9.7 mo, progression-free survival (PFS) (OS) 6.3 CI: 4.5–9.7) 10.9 7.4–NE), respectively. Conclusions: Our novel triplet combination, Pola-R-Len, demonstrates tolerable safety profile. This first efficacy shows promising activity difficult-to-treat population, particularly CR, large proportion whom Further evaluation impact is warranted address significant unmet need this patient population. Clinical trial information: NCT02600897. [Table: see text]