Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster II
Hematology Disease Topics & Pathways:
Biological, antibodies, Adult, Diseases, Hodgkin Lymphoma, Therapies, immunotherapy, Lymphoid Malignancies, Study Population
METHODS: Pts ≥ 18 years with relapsed or refractory cHL after standard therapy including BV and anti-PD1 Ab were included in this two-stage trial (NCT02321592). In stage I pts were initially assigned in a 1:1 ratio to either Arm A with 1.5 mg/kg AFM13 3x/ week for 8 weeks or Arm B with 1.5 mg/kg AFM13 3x/ week for 2 weeks followed by 1 infusion of 7.0 mg/kg/week for 6 weeks.
After an amendment to this trial, all further pts received 7 mg/kg per week, with 1 mg/kg loading dose and 6 mg/kg as continuous infusion for 5 days/ week thereafter (Arm C). If ≥ 2 overall responders were observed in 10 pts, the respective trial arm qualified for stage 2. Primary endpoint was the objective response (complete/partial remission (CR/PR)) after the first cycle. Secondary endpoints included efficacy (Overall survival (OS), Progression free survival (PFS)) and safety analyses.
RESULTS: Between June 26, 2015 and May 31, 2019, 25 pts were assigned to arm A (n=5), B (n=12), or C (n=8), respectively, and qualified for statistical analyses. Median age of the study population was 45 (range 21-73) years. 24/25 patients were male. Clinical stages 2, 3 and 4 were diagnosed in 8 (32%), 9 (36%), and 8 (32%) patients, respectively. Patients had received a median of 3 (range 1-11) salvage-therapy lines after first-line therapy. Since the trial was terminated in stage I due to a lack of recruitment, all statistical analyses of primary and secondary endpoints are also of descriptive nature. The central response evaluation panel included 24 of 25 pts: The objective response rate was 16.6% including 1 complete response (CR) and 3 partial responses (PR). Stable disease (SD) was documented in 6 pts and progressive disease (PD) in 14 pts. The responses were distributed as follows to the treatment arms: Two responses were documented in arm C and one response was documented in arm A and B, respectively. Second cycle AFM13 was started in 5 patients. Two patients had PD during or after cycle 2, and one patient each was diagnosed with CR, PR, or SD. During follow-up, there were 22 cases of PD and 9 deaths. With a median observation time for PFS of 5.5 months (95% CI 2.6 – 11.0), the 12-months PFS estimate was 12.6% (95%-CI 3.2 – 28.9) (Fig.1). With a median observation time of 14.5 months (95% CI 12.9-16.8) the 12-months OS estimate was 62% (95% CI 39.6-78.1). In only 5/25 pts serious adverse events due to hospitalization were observed; two events were characterized as serious adverse reaction: one CTC grade 4 and one CTC grade 2 infusion related reaction. All events resolved completely.
CONCLUSION: Treatment with AFM13 was well tolerated and showed modest activity in heavily pretreated pts. The responses documented in arm C qualified this arm with continuous AFM13 application over 5 days for further evaluation in trial stage 2 and thus indicated its potential. However, the trial was prematurely stopped due to low recruitment leading to the conclusion that the acceptance of the application schedule is extremely important.
Disclosures: Hüttmann: Roche: Other: Travel expenses; Seattle Genetics: Research Funding; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Gilead: Honoraria; Celgene: Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Lead Discovery Center GmbH: Consultancy; University Hospital Essen, University of Duisburg-Essen, Essen, Germany: Current Employment. Grosse-Thie: Abbvie: Other: Travel Grants; Bristol-Myers Squibb: Honoraria, Other: Travel Grants; Amgen: Honoraria; Novartis: Honoraria; Daiichi Sankyō: Other: Travel Grants. von Tresckow: Kite/Gilead: Honoraria; Pfizer: Honoraria; Amgen: Honoraria; Takeda: Honoraria, Other: Travel support, Research Funding; Novartis: Other: Travel support, Research Funding; Takeda: Honoraria, Other: Travel support, Research Funding; MSD Sharp & Dohme: Honoraria, Research Funding; Roche: Honoraria. Fuchs: Takeda: Honoraria; Celgene: Honoraria; Amgen: Honoraria; Bristol Myers Squibb: Honoraria, Research Funding; Affimed: Honoraria. Borchmann: Takeda: Research Funding; Bristol Myers Squibb: Research Funding. Engert: Takeda: Honoraria, Research Funding; MSD Sharp & Dohme: Honoraria; Bristol Myers Squibb: Honoraria, Research Funding; Affimed Therapeutics: Research Funding; AstraZeneca: Honoraria; Sandoz: Honoraria.
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