ADC Therapeutics Announces Positive Initial Data from LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Bispecific Antibody in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma
ADC Therapeutics (NYSE: ADCT) announced positive initial data from the LOTIS-7 Phase 1b trial evaluating ZYNLONTA® in combination with glofitamab for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The combination demonstrated a 94% best overall response rate and 72% complete response rate in evaluable patients.
The study included 29 B-NHL patients, with 18 evaluable 2L+ DLBCL patients receiving doses of 120 µg/kg or 150 µg/kg. At the 150µg/kg dose level, the combination achieved a 100% overall response rate and 78% complete response rate. Safety data showed no dose-limiting toxicities, with manageable Grade 3+ adverse events including neutropenia (24%), lymphopenia (7%), and hypokalemia (7%).
ADC Therapeutics (NYSE: ADCT) ha annunciato dati iniziali positivi dal trial di fase 1b LOTIS-7 che valuta ZYNLONTA® in combinazione con glofitamab per il linfoma diffuso a grandi cellule B (DLBCL) in recidiva/rifrattario. La combinazione ha mostrato un tasso di risposta globale migliore del 94% e un tasso di risposta completa del 72% nei pazienti valutabili.
Lo studio ha incluso 29 pazienti con B-NHL, di cui 18 pazienti DLBCL in seconda linea valutabili, che hanno ricevuto dosi di 120 µg/kg o 150 µg/kg. Al livello di dose di 150 µg/kg, la combinazione ha ottenuto un tasso di risposta globale del 100% e un tasso di risposta completa del 78%. I dati di sicurezza non hanno mostrato tossicità limitanti alla dose, con eventi avversi gestibili di Grado 3+ che includevano neutropenia (24%), linfopenia (7%) e ipokalemia (7%).
ADC Therapeutics (NYSE: ADCT) anunció datos iniciales positivos del ensayo de fase 1b LOTIS-7 que evalúa ZYNLONTA® en combinación con glofitamab para el linfoma difuso de células B grandes (DLBCL) en recaída/refractario. La combinación demostró una tasa de respuesta global máxima del 94% y una tasa de respuesta completa del 72% en pacientes evaluables.
El estudio incluyó a 29 pacientes con B-NHL, de los cuales 18 pacientes con DLBCL en segunda línea eran evaluables y recibieron dosis de 120 µg/kg o 150 µg/kg. En el nivel de dosis de 150 µg/kg, la combinación logró una tasa de respuesta global del 100% y una tasa de respuesta completa del 78%. Los datos de seguridad mostraron que no hubo toxicidades limitantes de dosis, con eventos adversos manejables de Grado 3+ que incluían neutropenia (24%), linfopenia (7%) e hipopotasemia (7%).
ADC Therapeutics (NYSE: ADCT)는 림프종 재발/내성 사례에 대해 ZYNLONTA®와 glofitamab의 병용요법을 평가하는 LOTIS-7 1b상 시험에서 긍정적인 초기 데이터를 발표했습니다. 이 조합은 평가 가능한 환자에서 94%의 최고 전체 반응률과 72%의 완전 반응률을 나타냈습니다.
본 연구는 29명 B-NHL 환자를 포함하였고, 그 중 18명의 2L+ DLBCL 환자가 120 µg/kg 또는 150 µg/kg의 용량을 투여받았습니다. 150µg/kg 용량에서 조합 요법은 100%의 전체 반응률과 78%의 완전 반응률을 달성했습니다. 안전성 데이터는 용량 제한 독성이 없었고, 관리 가능한 3등급 이상 부작용으로는 호중구감소증(24%), 림프구감소증(7%), 저칼륨혈증(7%)이 포함되었습니다.
ADC Therapeutics (NYSE: ADCT) a annoncé des données initiales positives de l'essai de phase 1b LOTIS-7 évaluant ZYNLONTA® en combinaison avec glofitamab pour le lymphome diffus à grandes cellules B (DLBCL) en rechute/résistant. La combinaison a montré un taux de réponse globale maximum de 94% et un taux de réponse complète de 72% chez les patients évaluables.
L'étude a inclus 29 patients atteints de B-NHL, dont 18 patients DLBCL de deuxième ligne évaluables, ayant reçu des doses de 120 µg/kg ou 150 µg/kg. Au niveau de dose de 150 µg/kg, la combinaison a atteint un taux de réponse globale de 100% et un taux de réponse complète de 78%. Les données de sécurité ont montré qu'il n'y avait pas de toxicités limitantes de dose, avec des événements indésirables gérables de grade 3+ comprenant une neutropénie (24%), une lymphopénie (7%) et une hypokaliémie (7%).
ADC Therapeutics (NYSE: ADCT) hat positive erste Daten aus der LOTIS-7 Phase 1b-Studie bekannt gegeben, die ZYNLONTA® in Kombination mit glofitamab bei rezidivierenden/refraktären diffusen großzelligen B-Zell-Lymphomen (DLBCL) bewertet. Die Kombination zeigte eine beste Gesamtansprechrate von 94% und eine komplette Ansprechrate von 72% bei auswertbaren Patienten.
Die Studie umfasste 29 Patienten mit B-NHL, von denen 18 evaluierbare DLBCL-Patienten in der zweiten Linie Dosen von 120 µg/kg oder 150 µg/kg erhielten. Bei der Dosis von 150 µg/kg erreichte die Kombination eine Gesamtansprechrate von 100% und eine komplette Ansprechrate von 78%. Die Sicherheitsdaten zeigten keine dosislimitierenden Toxizitäten, während verwaltungsgerechte Grad 3+ unerwünschte Ereignisse, einschließlich Neutropenie (24%), Lymphopenie (7%) und Hypokaliämie (7%), auftraten.
- 94% best overall response rate (ORR) in evaluable patients
- 72% complete response rate (CR) across all dose levels
- 100% ORR and 78% CR at 150µg/kg dose level
- 12 out of 13 complete responders maintain CR status
- No dose-limiting toxicities observed across all dose levels
- 24% of patients experienced Grade 3+ neutropenia
- 34.5% of patients showed Grade 1 or 2 Cytokine Release Syndrome
Insights
ZYNLONTA in combination with glofitamab demonstrated clinically meaningful benefit with
Safety data show no dose-limiting toxicities (DLTs), no high-grade cytokine release syndrome (CRS) or high-grade immune effector cell-associated neurotoxicity syndrome (ICANS) across all patients
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"We are excited by the strong initial results observed with ZYNLONTA plus glofitamab in second line plus patients with relapsed or refractory DLBCL," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We believe these data support our hypothesis that combining these two potent, approved, single-agent-drugs with complementary mechanisms of action will yield additive or synergistic efficacy, and a manageable safety profile given no overlapping non-hematologic toxicities, enabling administration across care settings. We are encouraged by the initial promising safety and efficacy data at both doses tested in the expansion arm."
Initial Clinical Data from Phase
An initial efficacy analysis was conducted on all 18 evaluable 2L+ DLBCL patients who received dose levels of 120 µg/kg (n=9) or 150 µg/kg (n=9) of ZYNLONTA plus the bispecific antibody glofitamab:
- Best overall response rate (ORR) was
94% (17/18) as assessed by Lugano criteria - Complete response (CR) was achieved in
72% (13/18) and partial response (PR) was achieved in22% (4/18) of patients. Of those achieving CR, 12 out of 13 remain in CR as of the cutoff date. - Among patients treated with ZYNLONTA at the 150µg/kg dose (the initial dose approved for ZYNLONTA as a monotherapy in 3L+ DLBCL patients), best ORR was
100% (9/9) and CR was achieved in78% (7/9) of patients
Encouraging efficacy data was observed across patients with different numbers of lines and types of prior treatments and across different histologies.
Initial safety data on all 29 patients suggest that ZYNLONTA plus glofitamab is generally well tolerated with no DLTs across all dose levels:
- Treatment emergent adverse events (TEAEs) of Grade 3 or higher occurring in ≥
5% of patients included neutropenia (24% ), lymphopenia (7% ) and hypokalemia (7% ) - Cytokine Release Syndrome (CRS) of Grade 1 or 2 according to ASTCT grading was observed in
34.5% of patients and resolved with standard treatment. Low-grade Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (Grade 2 according to ASTCT grading) was observed in two patients and both had complete resolution of symptoms. No Grade 3 or higher CRS or ICANS were observed. - There were no Grade 5 TEAEs observed
"These compelling initial results support the potential of ZYNLONTA plus the bispecific glofitamab to be a best-in-class combination in a highly competitive market," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We look forward to completing enrollment of dose expansion in the first half of 2025 and plan to engage with regulatory authorities on the path forward as data including additional patients with longer follow-up become available."
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About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.
ADC Therapeutics is based in Lausanne (Biopôle),
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
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