...Documented CD20 positive mature B cell neoplasm or CD20+ MCL...

Adults with R/R CD20+ DLBCL who had failed or were ineligible for ASCT were enrolled...The ORR was 91% (31/34), with 59% (20/34) of patients achieving complete metabolic response (CMR). Median times to response and CMR were 1.5 mo and 2.6 mo, respectively. The ORR and CMR rates were 94% and 39% among patients with primary refractory disease, 89% and 78% among patients ≥75 y of age, and 90% and 50% among patients with IPI ≥3 (Table)...Epcoritamab SC + GemOx led to high CMR rates in this difficult-to-treat R/R DLBCL population ineligible for transplant with high unmet medical need.

AbbVie...announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization for epcoritamab (TEPKINLY®) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy....AbbVie's application for the approval of epcoritamab is supported by results from the pivotal EPCORE™ NHL-1 Phase 1/2 open-label, multi-center trial evaluating the preliminary efficacy and safety of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including DLBCL. The primary endpoint of the study was overall response rate, as assessed by an independent review committee (63.1 percent).

Pts with R/R CD20+ LBCL received SC epcor (step-up priming and intermediate doses followed by 48-mg full doses) in 28-d cycles (Cs): QW, C1–3; Q2W, C4–9; Q4W, C≥10 until PD or unacceptable toxicity….LBCL overall response and CR rates were 63.1% and 39.5%, respectively, and were consistent for DLBCL (61.9% and 39.6%).

Pts with 1L CD20+ DLBCL and IPI ≥3 received subcutaneous epcoritamab (cycle [C] 1–4, QW; C5–6, Q3W) + R-CHOP for 6 Cs (21 d each) followed by epcoritamab monotherapy Q4W (28-d Cs) up to a total of 1 y….Subcutaneous epcoritamab + R-CHOP induces high CMR rates with a manageable safety profile in pts with 1L high-risk DLBCL, including double-hit/triple-hit pts.

...adults with relapsed or refractory CD20+ large B-cell lymphoma and at least two prior therapy lines (including anti-CD20 therapies) received subcutaneous epcoritamab...At a median follow-up of 10.7 months, the overall response rate was 63.1% (95% CI, 55.0 to 70.6) and the complete response rate was 38.9% (95% CI, 31.2 to 46.9)....Subcutaneous epcoritamab resulted in deep and durable responses and manageable safety in highly refractory patients with large B-cell lymphoma, including those with prior CAR T-cell exposure.

Genmab A/S...today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

Adults with previously untreated CD20+ DLBCL and IPI ≥3 received SC epco (every week, cycle [C] 1–4; every 3 weeks, C5–6) + R-CHOP for 6 cycles…the overall response rate (ORR) was 96% (24/25); 68% (17/25) had complete metabolic response (CMR). For the 10 pts who received 6 cycles of R-CHOP and had a subsequent response assessment, the ORR and CMR rate were 100% and 90%, respectively...all of these 10 pts remained in response, with the longest duration of response 7.1+ mo and ongoing....The safety profile of epco + R-CHOP is manageable....ORR and CMR rate were high with no relapses as of the data cutoff date.

Subcutaneous epcoritamab in combination with R-DHAX/C in pts with R/R DLBCL had a manageable safety profile. CRS events were of low grade and resolved with standard management. ORR and CMR rate were high. At the time of data cutoff, 70% of pts had either received ASCT or continued epcoritamab Tx in CMR.

Adults with R/R CD20+ DLBCL who failed or were ineligible for ASCT received epco (QW, cycle [C] 1–3; Q2W, C4–9; Q4W, C≥10) and GemOx (Q2W, C1–4)….Response is shown in the Table. At the time of data cut, 65% of responders remained in response with the longest duration of response 6.9 mo. All 3 pts with prior CAR T remained on Tx and in response (2 CMR and 1 partial metabolic response [PMR]).

Adults with R/R CD20+ B-NHL received flat-dose 1 mL SC epcoritamab (step-up dosing approach) in 28-day cycles…Overall response rates (ORRs) for patients with DLBCL at doses ≥12 mg (n = 22) and ≥48 mg (n = 11) were 68% (CR = 46%; PR = 23%) and 91% (CR = 55%; PR = 36%), respectively.

Adults with R/R CD20+ B-NHL received flat-dose 1 mL SC epcoritamab (step-up dosing approach) in 28-day cycles....68 pts with B-NHL were enrolled across histologies including diffuse large B-cell lymphoma (DLBCL; n = 46 [67.6%]; de novo and transformed), follicular lymphoma (FL; 12 [17.6%])....Overall response is shown for DLBCL ≥12 mg and ≥48 mg and FL ≥12 mg, corresponding to the minimal efficacy threshold (Table). Responses deepened over time (PR converted to CR: DLBCL, 6 pts; FL, 3 pts)...SC epcoritamab demonstrated substantial single-agent activity, inducing deep and durable clinically meaningful responses, with a consistent safety profile.

Adults with R/R CD20+ B-NHL….58 patients with a median (range) age 68 (21–84) years were enrolled. Most patients had DLBCL (67.2%) or FL (19.0%) and received a median (range) of 3 (1–6) and 5 (1–18) prior lines of treatment, respectively….Antitumor activity (14 May 2020) in evaluable patients with DLBCL...DLBCL (n=15): ORR 60.0% (CR: 20.0%; PR: 40.0%), SD: 6.7%, PD: 33.3%. FL (n=7): ORR 85.7% (PR: 85.7%), SD: 14.3%,...

Treatment is ongoing in 20 patients. Antitumor activity (14 May 2020) in evaluable patients with DLBCL (≥12mg) and FL (≥0.76mg) are: DLBCL (n=15): ORR 60.0% (CR: 20.0%; PR: 40.0%), SD: 6.7%, PD: 33.3%. FL (n=7): ORR 85.7% (PR: 85.7%), SD: 14.3%, no patients with PD. One patient with DLBCL de novo achieved a response post-data cutoff. Median (range) time to response was 1.6 (1–4) months.The safety, efficacy, and pharmacokinetics data support epcoritamab 48 mg SC (1 mL, single dose) to be explored in the expansion phase. SC epcoritamab continues to demonstrate a favorable safety profile consistent with previous reported data.