ALX Oncology Presents Positive Updated Data from ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Generates Strong Response and Durable Clinical Benefit in Patients with HER2-Positive Gastric Cancer
ALX Oncology (ALXO) announced updated positive data from the ASPEN-06 Phase 2 trial of evorpacept in HER2-positive gastric cancer patients. The trial demonstrated significant improvements in patients with confirmed HER2-positive cancer, showing a 48.9% overall response rate and 15.7 months median duration of response compared to 24.5% and 9.1 months in the control group.
The study evaluated evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel (ETRP) against the standard treatment (TRP). In patients with confirmed HER2-positive expression, the treatment showed a progression-free survival Hazard Ratio of 0.64. The drug was well-tolerated, with adverse events consistent with the control group.
The FDA has granted Fast Track designation for evorpacept in second-line treatment of HER2-positive gastric cancer, with both FDA and European Commission providing Orphan Drug Designation.
ALX Oncology (ALXO) ha annunciato dati aggiornati e positivi dall trial di fase 2 ASPEN-06 su evorpacept in pazienti con cancro gastrico HER2-positivo. Lo studio ha dimostrato significativi miglioramenti nei pazienti con cancro HER2-positivo confermato, mostrando un tasso di risposta complessivo del 48,9% e una durata mediana della risposta di 15,7 mesi rispetto al 24,5% e 9,1 mesi nel gruppo di controllo.
Lo studio ha valutato evorpacept in combinazione con trastuzumab, ramucirumab e paclitaxel (ETRP) rispetto al trattamento standard (TRP). Nei pazienti con espressione HER2-positivo confermata, il trattamento ha mostrato un Hazard Ratio di sopravvivenza libera da progressione di 0,64. Il farmaco è stato ben tollerato, con eventi avversi in linea con il gruppo di controllo.
La FDA ha concesso la designazione Fast Track per evorpacept nel trattamento di seconda linea del cancro gastrico HER2-positivo, ricevendo inoltre la designazione di Farmaco Orfano sia dalla FDA che dalla Commissione Europea.
ALX Oncology (ALXO) anunció datos positivos actualizados del ensayo de fase 2 ASPEN-06 sobre evorpacept en pacientes con cáncer gástrico HER2-positivo. El ensayo demostró mejoras significativas en pacientes con cáncer HER2-positivo confirmado, mostrando una tasa de respuesta general del 48.9% y una duración media de respuesta de 15.7 meses en comparación con el 24.5% y 9.1 meses en el grupo de control.
El estudio evaluó evorpacept en combinación con trastuzumab, ramucirumab y paclitaxel (ETRP) en comparación con el tratamiento estándar (TRP). En pacientes con expresión HER2-positivo confirmada, el tratamiento mostró una razón de riesgo de supervivencia libre de progresión de 0.64. El medicamento fue bien tolerado, con eventos adversos consistentes con el grupo de control.
La FDA ha otorgado la designación de Fast Track para evorpacept en el tratamiento de segunda línea del cáncer gástrico HER2-positivo, y tanto la FDA como la Comisión Europea han otorgado la designación de Medicamento Huérfano.
ALX Oncology (ALXO)는 HER2 양성 위암 환자를 대상으로 한 evorpacept의 ASPEN-06 2상 시험에서 업데이트된 긍정적인 데이터를 발표했습니다. 이 시험은 확인된 HER2 양성 암 환자에서 치료가 48.9%의 전체 반응률과 15.7개월의 중앙 반응 지속 기간을 보였으며, 이는 대조군의 24.5%와 9.1개월에 비해 유의미한 개선을 나타냅니다.
이 연구는 evorpacept를 trastuzumab, ramucirumab, paclitaxel(ETRP)과 병용하여 표준 치료(TRP)와 비교하였습니다. 확인된 HER2 양성 표현을 가진 환자에서는 치료가 무진행 생존율 위험비 0.64를 보였습니다. 이 약물은 대조군과 일치하는 부작용으로 잘 견디는 것으로 나타났습니다.
FDA는 HER2 양성 위암의 2차 치료에 대해 evorpacept에게 신속 심사(Fast Track) 지정을 부여하였으며, FDA와 유럽 연합에서 모두 희귀의약품 지정을 받았습니다.
ALX Oncology (ALXO) a annoncé des données positives mises à jour de l'essai de phase 2 ASPEN-06 concernant l'evorpacept chez des patients atteints de cancer gastrique HER2-positif. L'essai a démontré des améliorations significatives chez les patients présentant un cancer HER2-positif confirmé, affichant un taux de réponse global de 48,9% et une durée médiane de réponse de 15,7 mois par rapport à 24,5% et 9,1 mois dans le groupe témoin.
L'étude a évalué l'evorpacept en combinaison avec le trastuzumab, le ramucirumab et le paclitaxel (ETRP) par rapport au traitement standard (TRP). Chez les patients présentant une expression HER2-positive confirmée, le traitement a affiché un ratio de risque de survie sans progression de 0,64. Le médicament a été bien toléré, avec des événements indésirables cohérents avec le groupe témoin.
La FDA a accordé à l'evorpacept la désignation Fast Track pour le traitement en deuxième ligne du cancer gastrique HER2-positif, avec à la fois la FDA et la Commission européenne fournissant la désignation de médicament orphelin.
ALX Oncology (ALXO) hat aktualisierte positive Daten aus der ASPEN-06-Phase-2-Studie zu evorpacept bei Patienten mit HER2-positivem Magenkrebs bekannt gegeben. Die Studie zeigte signifikante Verbesserungen bei Patienten mit bestätigtem HER2-positivem Krebs und erreichte eine gesamtansprechrate von 48,9% sowie eine mediane Ansprechdauer von 15,7 Monaten im Vergleich zu 24,5% und 9,1 Monaten in der Kontrollgruppe.
Die Studie bewertete evorpacept in Kombination mit Trastuzumab, Ramucirumab und Paclitaxel (ETRP) im Vergleich zur Standardbehandlung (TRP). Bei Patienten mit bestätigter HER2-positiver Expression zeigte die Behandlung ein Fortschreiten-freies Überlebens-Verhältnis von 0,64. Das Medikament wurde gut vertragen, mit unerwünschten Ereignissen, die mit der Kontrollgruppe übereinstimmten.
Die FDA hat evorpacept für die Zweitlinientherapie von HER2-positivem Magenkrebs den Fast Track-Status verliehen, und sowohl die FDA als auch die Europäische Kommission haben die Orphan Drug Designation erteilt.
- 48.9% overall response rate in HER2-positive patients vs 24.5% in control group
- 15.7 months median duration of response vs 9.1 months in control group
- FDA Fast Track and Orphan Drug designations received
- Well-tolerated safety profile comparable to control group
- Overall survival data not yet mature
- efficacy in non-HER2-positive patients
Insights
The ASPEN-06 trial results represent a significant breakthrough in CD47 inhibitor development, marking the first time a CD47 blocker has demonstrated substantial tumor response in a randomized trial. The data reveals several important insights:
The efficacy metrics are particularly impressive in the biomarker-positive population, with 48.9% ORR in HER2-positive patients (confirmed by fresh biopsy or ctDNA) compared to 24.5% in the control group. The 15.7-month median duration of response suggests durable benefit, a critical factor for both regulatory approval and clinical adoption.
Three aspects make these results particularly noteworthy:
- The consistent benefit across multiple subgroups validates evorpacept's mechanism of action in HER2-positive cancers
- The well-tolerated safety profile differentiates it from other CD47 inhibitors, which have historically struggled with safety concerns
- The Fast Track and Orphan Drug designations, combined with these positive data, suggest an accelerated pathway to potential approval
The biomarker strategy, focusing on HER2-positive patients, appears particularly successful, with the strongest benefits observed in patients with confirmed HER2 expression. This could streamline the path to market and potentially lead to a companion diagnostic development.
The ASPEN-06 results potentially position ALX Oncology to capture a significant share of the HER2-positive gastric cancer market, particularly in the second-line setting. Several market dynamics make these results commercially significant:
The demonstrated efficacy in previously treated patients addresses a critical market gap, as resistance to HER2-targeted therapies remains a major challenge in gastric cancer treatment. The combination strategy with established agents could facilitate rapid market adoption if approved.
Key commercial considerations include:
- The potential for broad reimbursement given the significant improvement in objective response rate and durability of response
- The possibility of expanding into other HER2-positive cancers, as suggested by recent breast cancer data
- The competitive advantage of a superior safety profile compared to other CD47 inhibitors
For ALX Oncology, with its current market cap of
- Oral presentation at 2025 ASCO Gastrointestinal Cancers Symposium today highlights evorpacept as the first CD47 blocker to show substantial tumor response and a well-tolerated safety profile in a prospective randomized trial
- Greatest benefit observed among patients with confirmed HER2-positive cancer, as demonstrated by either fresh biopsy or ctDNA HER2-expression, with confirmed ORR of
48.9% and mDOR of 15.7 months vs.24.5% ORR and mDOR of 9.1 months in the control group, and a PFS Hazard Ratio of 0.64 - Company to host conference call and investor webcast today at 1:00 PM PT/4:00 PM ET
SOUTH SAN FRANCISCO, Calif., Jan. 23, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, announced positive updated data from the ASPEN-06 Phase 2 clinical trial demonstrating that the company’s investigational CD47-blocker evorpacept generates a durable clinical response with a well-tolerated safety profile among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The updated results, which build upon previously announced topline results, will be shared today in an oral presentation (Abstract #332) at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco.
“The updated data from the ASPEN-06 trial highlight the potential clinical utility of CD47 inhibition from evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with previously treated HER2-positive gastric cancer,” said Kohei Shitara, M.D., Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan and the study’s presenter. “Overall, the findings suggest that evorpacept generates durable and clinically meaningful anti-tumor activity in this population of patients who had previously received a HER2-targeted agent, with the largest benefit among those patients with confirmed HER2-positive disease.”
ASPEN-06 is a randomized, multi-center, international trial (NCT05002127) evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA® (ramucirumab) and paclitaxel (collectively, ETRP) against trastuzumab, ramucirumab and paclitaxel (TRP) alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients were enrolled with either archival or fresh HER2-positive biopsies.
The trial’s primary endpoints were investigator-assessed overall response rate (ORR) in the intent-to-treat (ITT) population and in the population of patients with fresh HER2-positive biopsies, compared to both internal control (TRP) and historical control (ramucirumab and paclitaxel, or RP). Key secondary endpoints were safety, duration of response (DOR), progression-free survival (PFS) and overall survival (OS). The updated dataset being presented today includes results from a December 2, 2024 data cut, including an analysis that assessed patients with HER2-positive tumors via circulating tumor DNA (ctDNA) at baseline. Overall survival data were not yet mature at the time of data cut.
Updated trial results to be shared today at 2025 ASCO GI include:
- Primary endpoints (December data cut):
- ITT patient population ORR (N=127): Evorpacept plus TRP (ETRP) demonstrated an ORR of
41.3% compared to30% for RP historical control and26.6% for TRP control. - Fresh HER2-positive biopsy patient population ORR (n=48): ETRP demonstrated an ORR of
59.1% compared to30% for RP historical control and23.1% for TRP control.
- ITT patient population ORR (N=127): Evorpacept plus TRP (ETRP) demonstrated an ORR of
- In the ITT population, ETRP demonstrated a median DOR (mDOR) of 15.7 months and a median PFS (mPFS) of 7.5 months compared to an mDOR of 9.1 months and mPFS of 7.4 months in the TRP control group, with a PFS Hazard Ratio (HR) in this population of 0.77.
- In patients with fresh HER2-positive biopsies, ETRP demonstrated an mDOR of 15.7 months and mPFS of 9.5 months compared to an mDOR of 14.5 months and 7.1 months in the TRP control group, with a PFS HR of 0.62.
- In patients with confirmed HER2-positive expression as determined by either fresh biopsy or ctDNA HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a
48.9% ORR, an mDOR of 15.7 months and mPFS of 7.5 months, compared to24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64. - Evorpacept plus TRP was generally well tolerated, with the incidence of adverse events in the evorpacept population consistent with those in TRP control.
“The results from this trial tell a clear story that when a cancer cell is expressing HER2, evorpacept can combine with a regimen containing an anti-HER2 antibody such as trastuzumab to improve upon the activity you would expect from that regimen alone,” said Alan Sandler, M.D., Chief Medical Officer at ALX Oncology. “This is evidenced by the near doubling of PFS at one year among the patients with HER2-positivity confirmed via either fresh biopsy or ctDNA who received ETRP vs control. Additionally, the analysis of this patient population affirms HER2-expression is a key biomarker for evorpacept efficacy and validates the strategy behind evorpacept’s novel design.”
The updated ASPEN-06 data add to positive findings from a Phase 1b/2 trial recently presented at the 2024 San Antonio Breast Cancer Symposium (SABCS). These findings suggested that patients with heavily pretreated HER2-positive advanced breast cancer had anti-tumor activity from CD47 inhibition with evorpacept when it is combined with a HER2-targeted agent.
“The dataset shared today from the ASPEN-06 randomized clinical trial suggests durable clinical benefit driven by evorpacept and a differentiated safety profile – a first for any CD47 blocker,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Based on the collective clinical data we’ve now seen across patients with HER2-positive gastric and breast cancers, we believe evorpacept is working as designed in combination with antibodies when there is HER2 expression, even when patients had been previously treated with other HER2-directed therapies. We look forward to sharing the updated ASPEN-06 data with the FDA and are confident in our path to pursue evorpacept as a therapeutic option for patients.”
A copy of the 2025 ASCO GI presentation will be available in the “Publications” section of the ALX Oncology website following the presentation.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication.
Company Conference Call and Webcast on January 23 at 1:00 PM PT/4:00 PM ET
ALX Oncology will host a conference call and webcast today at 1:00 PM PT/4:00 PM ET to review the updated ASPEN-06 data. The event will be webcast live and a replay will be available after the call by visiting the “Investors” section of ALX Oncology’s website and selecting “Events and Presentations”.
Date & Time: Thursday, January 23, 1:00 PM PT/4:00 PM ET
Webcast Access: https://edge.media-server.com/mmc/p/ipy66o44
About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system 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 objects 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
What were the key results of ALXO's ASPEN-06 Phase 2 trial for evorpacept?
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