ALX Oncology Announces Encouraging Final Results from Phase 1 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with B-cell Non-Hodgkin Lymphoma
ALX Oncology (ALXO) has announced final results from a Phase 1 trial evaluating evorpacept in combination with rituximab and lenalidomide (R2) for B-cell non-Hodgkin lymphoma. The study demonstrated promising outcomes with 83% complete response rate in indolent NHL patients, significantly higher than the 34% historical rate with R2 alone.
The trial enrolled 20 patients, including 18 with indolent and 2 with aggressive R/R B-NHL. Key findings include:
- Two-year progression-free survival rate of 69%
- Two-year overall survival rate of 84%
- 90% best overall response rate
- Well-tolerated treatment with no dose-limiting toxicities
The Phase 2 portion of the trial in previously untreated indolent NHL patients has completed enrollment. Results will be presented at the AACR 2025 Annual Meeting.
ALX Oncology (ALXO) ha annunciato i risultati finali di uno studio di Fase 1 che ha valutato evorpacept in combinazione con rituximab e lenalidomide (R2) per il linfoma non-Hodgkin a cellule B. Lo studio ha mostrato risultati promettenti con un tasso di risposta completa dell'83% nei pazienti con NHL indolente, significativamente superiore al 34% storico ottenuto con R2 da solo.
Lo studio ha arruolato 20 pazienti, di cui 18 con NHL indolente e 2 con NHL B-R/R aggressivo. I risultati principali includono:
- tasso di sopravvivenza libera da progressione a due anni del 69%
- tasso di sopravvivenza globale a due anni dell'84%
- tasso di risposta complessiva migliore del 90%
- trattamento ben tollerato senza tossicità limitanti la dose
La parte di Fase 2 dello studio, condotta su pazienti con NHL indolente non trattati in precedenza, ha completato l’arruolamento. I risultati saranno presentati all’AACR 2025 Annual Meeting.
ALX Oncology (ALXO) ha anunciado los resultados finales de un ensayo de Fase 1 que evaluó evorpacept en combinación con rituximab y lenalidomida (R2) para el linfoma no Hodgkin de células B. El estudio mostró resultados prometedores con una tasa de respuesta completa del 83% en pacientes con NHL indolente, significativamente superior al 34% histórico con solo R2.
El ensayo incluyó a 20 pacientes, de los cuales 18 tenían NHL indolente y 2 NHL B-R/R agresivo. Los hallazgos clave incluyen:
- tasa de supervivencia libre de progresión a dos años del 69%
- tasa de supervivencia global a dos años del 84%
- tasa de mejor respuesta global del 90%
- tratamiento bien tolerado sin toxicidades limitantes de dosis
La fase 2 del ensayo en pacientes con NHL indolente no tratados previamente ha completado la inscripción. Los resultados se presentarán en la Reunión Anual AACR 2025.
ALX Oncology (ALXO)는 B세포 비호지킨 림프종을 대상으로 리툭시맙과 레날리도마이드(R2)와 병용한 에보르페셉트의 1상 임상시험 최종 결과를 발표했습니다. 연구 결과, 인돌런트 NHL 환자에서 완전 반응률 83%로 R2 단독의 과거 34% 대비 현저히 높은 유망한 결과를 보였습니다.
총 20명의 환자가 등록되었으며, 이 중 18명은 인돌런트, 2명은 공격적인 재발/불응성 B-NHL 환자였습니다. 주요 결과는 다음과 같습니다:
- 2년 무진행 생존율 69%
- 2년 전체 생존율 84%
- 최고 전체 반응률 90%
- 용량 제한 독성 없이 잘 견디는 치료
이전에 치료받지 않은 인돌런트 NHL 환자를 대상으로 한 2상 시험은 등록을 완료했습니다. 결과는 2025년 AACR 연례회의에서 발표될 예정입니다.
ALX Oncology (ALXO) a annoncé les résultats finaux d’un essai de Phase 1 évaluant l'evorpacept en association avec le rituximab et la lénalidomide (R2) pour le lymphome non hodgkinien à cellules B. L’étude a montré des résultats prometteurs avec un taux de réponse complète de 83% chez les patients atteints de LNH indolent, nettement supérieur au taux historique de 34% avec R2 seul.
L’essai a inclus 20 patients, dont 18 avec un LNH indolent et 2 avec un LNH B-R/R agressif. Les principales conclusions sont :
- taux de survie sans progression à deux ans de 69%
- taux de survie globale à deux ans de 84%
- meilleur taux de réponse globale de 90%
- traitement bien toléré sans toxicités limitant la dose
La phase 2 de l’essai chez des patients atteints de LNH indolent non traités auparavant a terminé son recrutement. Les résultats seront présentés lors de la réunion annuelle AACR 2025.
ALX Oncology (ALXO) hat die endgültigen Ergebnisse einer Phase-1-Studie bekannt gegeben, in der Evorpacept in Kombination mit Rituximab und Lenalidomid (R2) bei B-Zell-Non-Hodgkin-Lymphom untersucht wurde. Die Studie zeigte vielversprechende Ergebnisse mit einer kompletten Ansprechrate von 83% bei Patienten mit indolentem NHL, was deutlich über der historischen Rate von 34% mit R2 allein liegt.
Die Studie umfasste 20 Patienten, davon 18 mit indolentem und 2 mit aggressivem rezidiviertem/refraktärem B-NHL. Wichtige Ergebnisse sind:
- zwei-Jahres progressionsfreies Überleben von 69%
- zwei-Jahres Gesamtüberleben von 84%
- beste Gesamtansprechrate von 90%
- gut verträgliche Behandlung ohne dosislimitierende Toxizitäten
Der Phase-2-Teil der Studie bei zuvor unbehandelten Patienten mit indolentem NHL hat die Rekrutierung abgeschlossen. Die Ergebnisse werden auf dem AACR 2025 Jahreskongress vorgestellt.
- 83% complete response rate in indolent NHL, significantly higher than 34% historical rate
- 90% best overall response rate achieved
- Strong survival metrics: 84% two-year OS rate and 69% two-year PFS rate
- Well-tolerated safety profile with no dose-limiting toxicities
- Phase 2 trial enrollment completed ahead of results
- 80% of patients had progressed within 24 months from frontline therapy
- sample size of only 20 patients in Phase 1 trial
Insights
Evorpacept shows significantly improved 83% complete response rate in NHL compared to 34% with standard therapy alone.
The Phase 1 results for evorpacept represent a potentially significant advancement in treating relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). The 83% complete response rate in indolent NHL patients substantially outperforms the 34% historical CR rate with rituximab+lenalidomide (R2) alone - a difference that could meaningfully impact patient outcomes if confirmed in larger studies.
The efficacy data is particularly compelling given the heavily pretreated population: 100% had prior rituximab exposure, 72% received chemoimmunotherapy, and 80% had progressed within 24 months of frontline therapy - typically indicators of more aggressive disease biology and treatment resistance.
The two-year survival metrics further validate the potential clinical benefit:
Mechanistically, evorpacept's ability to block CD47 (the "don't eat me" signal) enhances macrophage-mediated phagocytosis of cancer cells when combined with rituximab. The documented increases in T-cells and anti-tumoral macrophages during treatment provide biological evidence supporting the synergistic mechanism of action.
The clean safety profile (no dose-limiting toxicities) addresses a major concern with CD47-targeting approaches, which historically faced challenges with thrombocytopenia and anemia. This favorable tolerability enables effective dosing and potentially broader applicability.
ALX Oncology's promising NHL trial results could significantly enhance company value if larger studies confirm these early findings.
These Phase 1 results represent a critical validation point for ALX Oncology's lead asset evorpacept and its CD47-blocking approach. With a current microscopic market cap of just
The company has strategically designed evorpacept as a combination therapy enhancer rather than monotherapy, evidenced by this trial with rituximab+lenalidomide. This approach addresses a key market need for treatments that overcome resistance to standard therapies without adding substantial toxicity.
The completion of enrollment in the Phase 2 portion represents near-term catalyst potential, as positive Phase 2 data would substantially de-risk the program. B-cell malignancies represent a multi-billion dollar market, with indolent lymphomas being chronic diseases requiring multiple lines of therapy.
In the competitive CD47 landscape, evorpacept's apparent lack of dose-limiting toxicities differentiates it from earlier CD47 inhibitors that struggled with hematological side effects. This trial demonstrates potential best-in-class profile with
- Data to be presented at AACR 2025 Annual Meeting suggest the combination of ALX Oncology’s investigational CD47-blocker, evorpacept, plus rituximab and lenalidomide (R2) was well-tolerated and demonstrated promising anti-tumor activity
- Combination generated complete responses (CR) in
- Phase 2 portion of trial in patients with previously untreated indolent NHL (iNHL) is ongoing and has completed enrollment
SOUTH SAN FRANCISCO, Calif., April 25, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced encouraging data from an ongoing Phase 1/2 investigator-sponsored trial (IST) of the company’s lead clinical candidate, evorpacept, in combination with standard-of-care rituximab and lenalidomide (R2) in patients with indolent and aggressive relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). Final results from the Phase 1 portion of the trial will be presented Tuesday, April 29, during a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois.
“In patients with indolent B-NHL, increases in certain pro-tumoral macrophages can promote resistance to important frontline standard-of-care treatments, including R2,” said Paolo Strati, M.D., the trial’s lead investigator and Associate Professor of Lymphoma-Myeloma at The University of Texas MD Anderson Cancer Center. “Evorpacept is uniquely designed to activate the innate immune system and engage macrophages to enhance the therapeutic benefits of and deepen responses to anti-cancer antibodies such as rituximab. This trial suggests evorpacept has a synergistic effect with R2 that may help improve outcomes and overcome resistance to R2 in this patient population.”
The clinical trial conducted by Dr. Strati and colleagues at MD Anderson enrolled a total of 20 patients with indolent (n=18) and aggressive (n=2) R/R B-NHL; all 20 had previously received an anti-CD20 monoclonal antibody (rituximab),
After a median follow-up of 28 months (
“The final results from this Phase 1 study reinforce evorpacept’s potential to meaningfully deepen and enhance responses to many of the most important cancer therapies available today, including anti-cancer antibodies such as rituximab, and to thereby help address significant, unmet needs in cancer treatment,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “We look forward to the continued evaluation of evorpacept in patients with previously untreated and high tumor-burden indolent NHL in the Phase 2 portion of this study.”
The Phase 2 portion of this IST in patients with previously untreated iNHL is ongoing and has completed enrollment.
Details of the poster to be presented at AACR 2025 are as follows:
Title: Final results of a phase I trial of evorpacept (ALX148), lenalidomide, and rituximab for patients with B-cell non-Hodgkin lymphoma
Presenter: Paolo Strati, M.D., Associate Professor of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center
Session Title: Late-Breaking Research: Clinical Research 3
Date/Time: Tuesday, April 29, 2025, from 2:00 p.m. - 5:00 p.m. CT
Location: McCormick Place Convention Center, Poster Section 53
Poster Board Number: 13
Published Abstract Number: LB369
A copy of the AACR 2025 IST presentation will be available in the “Publications” section of the ALX Oncology website following the presentation.
About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.
Cautionary note regarding forward-looking statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com
Media Contact:
Audra Friis, Sam Brown, Inc.
audrafriis@sambrown.com
(917) 519-9577
FAQ
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