This section highlights FDA-related milestones and regulatory updates for drugs developed by ALX Oncology (ALXO).
Over the past two years, ALX Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALX2004, Evorpacept, ASPEN-06, and ASPEN-04. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ALX2004 FDA Regulatory Timeline and Events
ALX2004 is a drug developed by ALX Oncology for the following indication: For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALX2004
- Announced Date:
- January 8, 2026
- Indication:
- For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors
Announcement
ALX Oncology Holdings Inc announced that the first patient has been dosed in the Company's Phase 2 ASPEN-09-Breast trial evaluating its investigational CD47-inhibitor evorpacept. .
AI Summary
ALX Oncology announced the first patient has been dosed in its Phase 2 ASPEN-09-Breast trial testing evorpacept, an investigational CD47 inhibitor. The study combines evorpacept with trastuzumab and a physician’s choice of chemotherapy in patients with HER2‑positive metastatic breast cancer whose disease progressed after prior treatment with trastuzumab deruxtecan (T‑DXd). The single‑arm, open‑label, multicenter trial plans to enroll about 80 patients and will use tumor CD47 expression as a biomarker to help assess response.
The trial’s primary endpoint is overall response rate (ORR) in patients confirmed HER2 positive by circulating tumor DNA (ctDNA). Key secondary endpoints include ORR by CD47 level, clinical benefit rate, duration of response, progression‑free survival, overall survival, and safety; an exploratory endpoint looks at ORR in ctDNA‑negative patients. ALX expects to report interim data in Q3 2026. Evorpacept has previously shown tumor responses and a tolerable safety profile in other studies, supporting further testing in this setting.
Read Announcement- Drug:
- ALX2004
- Announced Date:
- October 23, 2025
- Indication:
- For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors
Announcement
ALX Oncology Holdings Inc today presented preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 – 26, 2025 in Boston, Massachusetts.
AI Summary
ALX Oncology presented preclinical data and the design of its Phase 1 trial for ALX2004 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts. The October 22–26, 2025 event featured two posters that highlighted this novel ADC’s potential against EGFR-expressing tumors.
ALX2004 is built on a matuzumab-derived antibody targeting EGFR and a proprietary topoisomerase I inhibitor payload. Preclinical tests showed strong anti-tumor activity and a favorable toxicity profile, setting it apart from earlier EGFR ADCs.
The ongoing ALX2004-01 trial is a first-in-human, open-label, multicenter study across multiple U.S. centers. It will evaluate safety, tolerability and early efficacy in patients with advanced or metastatic EGFR-expressing solid tumors. Enrollment began in August 2025.
Initial safety data are expected in the first half of 2026. A second poster detailed the study’s dosing plan and goals to measure safety, tolerability and early signs of efficacy.
Read Announcement- Drug:
- ALX2004
- Announced Date:
- August 19, 2025
- Indication:
- For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors
Announcement
ALX Oncology Holdings Inc announced that the first patient has been dosed in the Company's Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors.
AI Summary
ALX Oncology Holdings Inc. announced that the first patient has been dosed in its Phase 1 clinical trial of ALX2004, a potential best- and first-in-class antibody-drug conjugate targeting EGFR-expressing solid tumors. This milestone marks the company’s first ADC trial and supports its goal of developing advanced cancer treatments.
ALX2004 is designed with an affinity-tuned EGFR antibody distinct from approved therapies, a stable linker, and a proprietary topoisomerase I inhibitor payload. Each component is optimized to maximize the therapeutic window and reduce off-target toxicity.
The open-label, first-in-human study includes a Phase 1a dose-escalation segment, followed by dose exploration and a Phase 1b expansion. It will enroll participants with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer.
Preclinical data demonstrated dose-dependent anti-tumor activity across diverse EGFR levels and mutations, along with a favorable safety profile and no EGFR-related skin toxicity or lung issues at clinically relevant doses. Initial safety results are expected in the first half of 2026.
Read Announcement- Drug:
- ALX2004
- Announced Date:
- May 20, 2025
- Indication:
- For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors
Announcement
ALX Oncology Holdings Inc provides an overview of the clinical development program for its highly-differentiated antibody-drug conjugate (ADC), ALX2004, at the Company's R&D webcast event today.
AI Summary
At its R&D webcast event today, ALX Oncology Holdings Inc. provided an overview of its clinical development program for ALX2004, a highly differentiated antibody-drug conjugate (ADC) designed to treat EGFR-expressing solid tumors. ALX2004 features a unique design that combines an affinity-tuned EGFR antibody with a proprietary linker and topoisomerase I inhibitor payload. This design aims to maximize the therapeutic window while reducing toxicity, offering the potential to overcome challenges observed with similar treatments in the past. The company shared preclinical data demonstrating robust activity across various tumor models and a favorable safety profile, which supports its further development. ALX Oncology plans to launch Phase 1 clinical studies for ALX2004 in mid-2025, with the initial safety data expected in the first half of 2026, signaling an exciting step forward in their cancer treatment pipeline.
Read Announcement- Drug:
- ALX2004
- Announced Date:
- April 7, 2025
- Indication:
- For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors
Announcement
ALX Oncology Holdings Inc announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company's potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors.
AI Summary
ALX Oncology Holdings Inc. announced that it has received U.S. Food and Drug Administration clearance for the Investigational New Drug (IND) application for its lead candidate, ALX2004. This potential best- and first-in-class antibody-drug conjugate (ADC) is specifically designed to treat solid tumors that express the epidermal growth factor receptor (EGFR). ALX2004 was entirely developed in-house using the company’s proprietary linker-payload platform, which integrates an optimized antibody backbone, a stable linker, and a potent topoisomerase I inhibitor payload. The design aims to target tumor cells more effectively while minimizing systemic toxicity. Based on this clearance, ALX Oncology plans to launch a Phase 1 clinical trial with a dose-escalation and expansion study scheduled to begin in mid-2025, with initial safety data expected in the first half of 2026.
Read Announcement
Evorpacept FDA Regulatory Events
Evorpacept is a drug developed by ALX Oncology for the following indication: For the Treatment of Patients with Gastric Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Evorpacept
- Announced Date:
- December 7, 2025
- Indication:
- For the Treatment of Patients with Gastric Cancer
Announcement
ALX Oncology Holdings Inc announced that positive data from a Phase 2 investigator-sponsored trial (IST) of evorpacept, in combination with standard-of-care rituximab and lenalidomide, for patients with indolent B-cell non-Hodgkin lymphoma (iNHL) is being presented Sunday, December 7 during a poster presentation at the American Society of Hematology (ASH) Annual Meeting 2025 in Orlando, Florida.
AI Summary
ALX Oncology reported positive Phase 2 investigator-sponsored trial results showing evorpacept combined with rituximab and lenalidomide (R2) produced complete responses (CR) in 92% of 24 patients with previously untreated indolent B‑cell non‑Hodgkin lymphoma (14 follicular, 10 marginal zone). The regimen achieved a 100% overall response rate (92% CR, 8% partial response), met the trial’s primary goal of a CR rate above 80%, and compared favorably to an approximate 50% historical CR rate for R2 alone. One‑year progression‑free survival was 91% and one‑year overall survival was 100%.
The combination was reported as well tolerated in this frontline, non‑chemotherapy setting. Results are being presented as a poster at the ASH Annual Meeting on Sunday, December 7, 2025, by Dr. Paolo Strati. Longer follow‑up will assess minimal residual disease (MRD) eradication and durability of responses. The data support blocking CD47 alongside rituximab to enhance tumor cell clearance.
Read Announcement- Drug:
- Evorpacept
- Announced Date:
- December 7, 2025
- Indication:
- For the Treatment of Patients with Gastric Cancer
Announcement
ALX Oncology Holdings Inc announced that positive data from a Phase 2 investigator-sponsored trial (IST) of evorpacept, in combination with standard-of-care rituximab and lenalidomide, for patients with indolent B-cell non-Hodgkin lymphoma (iNHL) is being presented Sunday, December 7 during a poster presentation at the American Society of Hematology (ASH) Annual Meeting 2025 in Orlando, Florida.
AI Summary
ALX Oncology reported positive Phase 2 investigator-sponsored trial results for evorpacept combined with rituximab and lenalidomide (R2) in untreated indolent B‑cell non-Hodgkin lymphoma (iNHL). In 24 frontline patients, the combination produced a complete response (CR) rate of 92%, compared with an approximate 50% historical CR rate for R2 alone. Overall response rate was 100%, one‑year progression‑free survival was 91%, and one‑year overall survival was 100%. Investigators described the regimen as well tolerated and showing impressive anti‑tumor activity as a non‑chemotherapy frontline option.
These data from the Phase 2 investigator‑initiated trial led by Dr. Paolo Strati will be presented as a poster at the American Society of Hematology (ASH) Annual Meeting on Sunday, December 7, 2025, in Orlando. Longer follow‑up will assess minimal residual disease (MRD) eradication to further define durability of responses.
Read Announcement- Drug:
- Evorpacept
- Announced Date:
- April 25, 2025
- Indication:
- For the Treatment of Patients with Gastric Cancer
Announcement
ALX Oncology Holdings Inc. 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).
AI Summary
ALX Oncology Holdings Inc. announced encouraging data from an ongoing Phase 1/2 investigator-sponsored trial evaluating its 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 (B-NHL). In this study, the combination was well-tolerated and showed promising anti-tumor activity. Notably, among patients with indolent B-NHL, an 83% complete response rate was observed—much higher than the historical 34% rate achieved with R2 alone. Evorpacept works as a CD47-blocker to activate the innate immune system and engage macrophages, which may help overcome resistance to R2. The Phase 2 part of the trial, focusing on patients with untreated indolent NHL, is currently ongoing and has completed enrollment.
Read Announcement
ASPEN-06 FDA Regulatory Timeline and Events
ASPEN-06 is a drug developed by ALX Oncology for the following indication: In Patients With HER2-Positive Gastric Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ASPEN-06
- Announced Date:
- October 3, 2025
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology Holdings Inc nnounced updated data from its Phase 2 ASPEN-06 (NCT05002127) trial will be presented during a poster session at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting taking place November 5–9, 2025, in National Harbor, Maryland.
AI Summary
ALX Oncology Holdings Inc., a clinical-stage biotechnology company, will present updated data from its Phase 2 ASPEN-06 trial at the SITC 40th Annual Meeting on Nov 5–9, 2025, in National Harbor, Maryland.
The data will appear in a poster session on Saturday, November 8, 2025, from 10:00 a.m. to 6:35 p.m. ET in Poster Hall (Exhibit Halls AB). The poster, by Zev A. Wainberg, M.D., is titled “CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer.”
ASPEN-06 is an international, multi-center Phase 2/3 trial of candidate evorpacept combined with HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel. The Phase 2 portion enrolled 127 adults with metastatic second- or third-line HER2-positive gastric or gastroesophageal junction cancer that progressed after prior therapies.
The updated results highlight CD47 overexpression as a key predictive biomarker for response to evorpacept. Findings may help guide future immuno-oncology approaches in this patient group.
Read Announcement- Drug:
- ASPEN-06
- Announced Date:
- March 6, 2025
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology Holdings Inc provided a corporate update.
AI Summary
ALX Oncology Holdings Inc. provided a corporate update detailing strong progress in its clinical development efforts with evorpacept. The company is focusing on a strategic development plan that includes new clinical trials to evaluate evorpacept in combination with anti-cancer antibodies in breast and colorectal cancers. They also introduced a novel EGFR-targeted antibody-drug conjugate candidate, ALX2004. ALX Oncology emphasized its approach to prioritizing operations and optimizing resources, including streamlining the organization, which is expected to extend its cash runway into the fourth quarter of 2026. The update highlighted significant momentum in ongoing clinical programs and announced key leadership additions. These include new appointments such as a Chief Business Officer, Chief Medical Officer, and Chief Financial Officer, as well as new board members to support the company's vision for long-term success in advancing innovative cancer treatments.
Read Announcement- Drug:
- ASPEN-06
- Announced Date:
- January 23, 2025
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology Holdings Inc. 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.
AI Summary
ALX Oncology Holdings Inc. announced positive updated results from the ASPEN-06 Phase 2 trial. The study showed that the company’s investigational CD47-blocker, evorpacept, produced a durable clinical response with a well-tolerated safety profile in patients with previously treated HER2-positive advanced gastric or gastroesophageal junction cancer. In the trial, patients with confirmed HER2-positive disease—determined either by fresh biopsy or circulating tumor DNA—experienced a markedly higher overall response rate of 48.9% compared to 24.5% in the control group. Additionally, the median duration of response improved to 15.7 months in the evorpacept arm versus 9.1 months in the control group. These findings suggest that evorpacept, when used alongside standard regimens, offers a promising therapeutic benefit in enhancing anti-tumor activity for this patient population.
Read Announcement- Drug:
- ASPEN-06
- Announced Date:
- January 21, 2025
- Target Action Date:
- January 23, 2025
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology Holdings Inc. announced that the company will host a virtual event on Thursday, January 23, at 1:00 p.m. PT/4:00 p.m. ET to discuss updated data from the ASPEN-06 Phase 2 clinical trial evaluating the company's investigational CD47-blocker evorpacept in patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
AI Summary
ALX Oncology Holdings Inc. announced a virtual event on Thursday, January 23 at 1:00 p.m. PT/4:00 p.m. ET. During the webcast, company leadership will review updated data from the ASPEN-06 Phase 2 clinical trial. This trial is focused on the investigational CD47-blocker evorpacept, which is being tested in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction (GEJ) cancer.
The updated data, first presented earlier on the same day at the 2025 ASCO Gastrointestinal Cancers Symposium, will now be discussed in more detail for investors and interested parties. The virtual event offers an opportunity to gain insights into the potential of evorpacept as an innovative treatment option that might improve outcomes for patients battling these aggressive cancers.
Read Announcement- Drug:
- ASPEN-06
- Announced Date:
- July 31, 2024
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology announced topline data from its Phase 2 ASPEN-06 clinical trial.
AI Summary
ALX Oncology announced topline data from its Phase 2 ASPEN-06 clinical trial, which evaluated evorpacept in combination with trastuzumab, CYRAMZA, and paclitaxel. The trial focused on patients with HER2-positive advanced gastric and gastroesophageal junction cancer who had previously been treated with HER2-targeted therapy. In the overall study population, the evorpacept combination achieved an overall response rate (ORR) of 40.3%, compared to 26.6% in the control arm. Notably, in patients with fresh HER2-positive biopsies, the ORR reached 54.8% versus 23.1% for the control group. The median duration of response for the evorpacept arm was 15.7 months compared to 7.6 months with the control treatment. These results validate evorpacept’s mechanism of action and support its continued development as a promising therapy in immuno-oncology.
Read Announcement
ASPEN-04 FDA Regulatory Events
ASPEN-04 is a drug developed by ALX Oncology for the following indication: For the Treatment of Head and Neck Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ASPEN-04
- Announced Date:
- April 25, 2025
- Indication:
- For the Treatment of Head and Neck Cancers
Announcement
ALX Oncology Holdings Inc announced topline data from its Phase 2 ASPEN-03 and ASPEN-04 clinical trials.
AI Summary
ALX Oncology Holdings Inc. announced topline data from its Phase 2 ASPEN-03 and ASPEN-04 trials evaluating evorpacept, a novel CD47-blocking agent, when combined with Merck’s KEYTRUDA® (pembrolizumab), with or without chemotherapy. The trials aimed to improve objective response rates in patients with advanced head and neck squamous cell carcinoma. However, the combination did not meet the primary endpoints compared to historical controls of pembrolizumab alone or in addition to chemotherapy. Despite these results, evorpacept demonstrated a manageable safety profile and showed promising trends in efficacy. ALX Oncology remains confident in evorpacept’s potential and will continue its clinical development in combination with other anti-cancer antibodies, based on durable clinical responses observed in previous trials with HER2-positive gastric and breast cancers. The company plans to pursue further studies in various tumor types to validate evorpacept’s unique mechanism of action.
Read Announcement
