ALX Oncology Announces Positive Results from Ongoing Investigator-Sponsored Phase 2 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with Indolent B-cell Non-Hodgkin Lymphoma, at ASH Annual Meeting

ALX Oncology (NASDAQ: ALXO) reported positive Phase 2 investigator‑sponsored data for evorpacept combined with rituximab and lenalidomide (R2) in untreated indolent B‑cell non‑Hodgkin lymphoma presented at ASH 2025.

Rhea-AI Summary

ALX Oncology (NASDAQ: ALXO) reported positive Phase 2 investigator‑sponsored data for evorpacept combined with rituximab and lenalidomide (R2) in untreated indolent B‑cell non‑Hodgkin lymphoma presented at ASH 2025.

In 24 frontline patients (14 follicular, 10 marginal zone), the regimen met its primary objective: 92% complete response (CR), 8% partial response, 100% overall response rate, one‑year PFS 91% and one‑year OS 100%. Investigators reported the combination was well tolerated; MRD evaluation and longer follow‑up were noted as next steps.

Positive

• CR 92% in 24 untreated iNHL patients
• ORR 100% (CR + PR)
• One‑year PFS 91%
• One‑year OS 100%
• Primary objective met: best CR rate > 80%

Negative

• Small cohort of 24 patients limits generalizability
• Longer follow‑up required to assess durability and MRD

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Key Figures

Complete response rate: 92% Historical CR rate: 50% Patients enrolled: 24 patients +5 more

Complete response rate

92%

Untreated iNHL patients on evorpacept + R2 in ongoing Phase 2 trial

Historical CR rate

50%

Approximate historical CR for R2 regimen alone in iNHL

Patients enrolled

24 patients

Previously untreated indolent B‑cell non‑Hodgkin lymphoma Phase 2 IST

Follicular lymphoma patients

14 patients

Subset with follicular lymphoma in Phase 2 iNHL trial

Marginal zone lymphoma patients

10 patients

Subset with marginal zone lymphoma in Phase 2 iNHL trial

Partial response rate

8%

Untreated iNHL patients on evorpacept + R2

Overall response rate

100%

Combined CR and PR in Phase 2 frontline iNHL trial

1-year PFS and OS

91% PFS, 100% OS

One-year outcomes for patients on evorpacept + R2

Historical Context

5 past events · Latest: Nov 18

5 events

1. Nov 18

   Investor conferences

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   Management scheduled fireside chats at two major healthcare conferences.

2. Nov 07

   Earnings & pipeline

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   Q3 2025 results and strong ASPEN‑06 exploratory evorpacept data in gastric cancer.

3. Oct 30

   Earnings preview

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   Upcoming Q3 report and SITC biomarker data preview for evorpacept.

4. Oct 23

   ALX2004 trial design

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   Preclinical data and Phase 1 design for EGFR‑targeted ADC ALX2004 presented.

5. Oct 03

   ASPEN‑06 update

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   Updated Phase 2 ASPEN‑06 data showing CD47 as predictive biomarker in gastric cancer.

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Key Terms

complete responses (CR), partial response (PR), overall response rate (ORR), progression free survival (PFS), +4 more

8 terms

complete responses (CR) medical

"generated complete responses (CR) in 92% of patients with untreated"

Complete responses (CR) describe when a patient’s measurable signs of disease disappear after treatment, meaning scans and clinical tests no longer detect the targeted condition. For investors, a higher CR rate in clinical trial results signals stronger evidence a therapy is working, which can increase the chance of regulatory approval, broaden market potential, and materially affect a company's valuation—think of it as a garden where all visible weeds have been cleared.

partial response (PR) medical

"8% achieved a partial response (PR), with the overall response rate"

Partial response (PR) is a clinical result in which a measurable disease—such as tumor size or cancer markers—shrinks by a predefined, meaningful amount but does not disappear, as judged by standard rules used in drug trials. For investors, a PR is evidence the therapy has real biological effect and can de‑risk development, yet it still leaves questions about how long the benefit lasts and whether it will translate into a clear commercial or regulatory win, similar to early customer uptake that shows promise but not full market dominance.

overall response rate (ORR) medical

"partial response (PR), with the overall response rate (ORR) being 100%"

Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.

progression free survival (PFS) medical

"One year progression free survival (PFS) rate was 91%, and one year"

Progression free survival (PFS) is the amount of time after a treatment starts during which a patient’s disease does not get worse. Investors watch PFS because it’s a commonly reported measure in clinical trials that can indicate a drug’s effectiveness earlier than overall survival, much like measuring how long a dam holds before leaks reappear; stronger PFS results can speed regulatory decisions and affect a drug’s commercial prospects.

overall survival (OS) medical

"progression free survival (PFS) rate was 91%, and one year overall survival (OS)"

Overall survival (OS) is the length of time from the start of a treatment or clinical study until death from any cause, essentially measuring how long patients live after a therapy begins. Investors watch OS because it is the most direct evidence a treatment extends life; stronger OS results can drive regulatory approvals, wider use and higher revenue expectations, much like sales figures proving a product actually works.

minimal residual disease (MRD) medical

"minimal residual disease (MRD) eradication rate with this novel regimen"

The presence of minimal residual disease (MRD) means a very small number of cancer cells remain in the body after treatment, too few to cause symptoms or show up on routine scans but detectable with sensitive tests. For investors it matters because MRD status is a strong early indicator of whether a patient is likely to relapse and is increasingly used as a trial endpoint and regulatory signal, affecting a therapy’s market prospects and valuation much like finding glowing embers after a fire signals risk of re-ignition.

Phase 2 medical

"positive data from a Phase 2 investigator-sponsored trial (IST) of evorpacept"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

CD47 medical

"marked by high CD47 expression, this data further supports the relevance"

A cell surface protein that acts like a “don’t eat me” signal to the immune system, helping healthy and some diseased cells avoid destruction by immune cells. Investors should care because therapies that block or modulate this protein are a major approach in cancer and immune disease drug development; clinical trial results, safety, and regulatory decisions around CD47-targeting treatments can strongly affect the value of companies developing them.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- Combination of evorpacept plus rituximab and lenalidomide (R²) generated complete responses (CR) in 92% of patients with untreated indolent non-Hodgkin lymphoma (iNHL) comparing favorably to an approximate 50% historical CR rate for R² alone

- Data indicates combination of evorpacept plus R² was well-tolerated and provides impressive anti-tumor activity in frontline treatment setting

- While longer follow up matures, minimal residual disease (MRD) eradication rate with this novel regimen will be evaluated

SOUTH SAN FRANCISCO, Calif., Dec. 07, 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 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.

“We are excited to see the results of this Phase 2 study in frontline indolent non-Hodgkin lymphoma patients, where the addition of evorpacept added a meaningful benefit over the historical data for the standard-of-care regimen of rituximab and lenalidomide,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Dr. Strati pursued this frontline study after seeing promising activity using the same combination in the relapsed refractory setting, which was previously published. Today, we are pleased to see this efficacy replicated in the frontline setting. Additionally, as non-Hodgkin lymphoma is a disease marked by high CD47 expression, this data further supports the relevance of blocking CD47 in the presence of an anti-cancer antibody, rituximab in this case, to allow for the destruction of cancer cells. We look forward to longer term follow up and the evaluation of MRD from this study.”

The clinical trial conducted by Dr. Paolo Strati, the trial’s lead investigator and Associate Professor of Lymphoma-Myeloma at The University of Texas MD Anderson Cancer Center, along with his colleagues enrolled a total of 24 patients with previously untreated iNHL, 14 patients with follicular lymphoma and 10 patients with marginal zone lymphoma. The primary objective of best CR rate above 80% was met with evorpacept added to R² in the context of a historical R² CR rate of 50%. The investigators found the addition of evorpacept to R² to be a well-tolerated frontline non-chemotherapy regimen for patients with iNHL, resulting in a high CR rate. 92% of patients achieved a complete response, and 8% achieved a partial response (PR), with the overall response rate (ORR) being 100%. One year progression free survival (PFS) rate was 91%, and one year overall survival (OS) rate was 100%.

Details of the poster to be presented at ASH 2025 are as follows:
Title: A phase II investigator-initiated frontline trial of evorpacept (ALX148), lenalidomide and rituximab for high tumor burden indolent B-cell non-Hodgkin lymphoma
Presenter: Paolo Strati, M.D., Associate Professor of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center
Presentation ID: 3571
Date/Time: December 7, 2025; 8:00 a.m. – 8:00 p.m. EST (poster session viewing); 6:00 p.m. – 8:00 p.m. EST (presentation)
Session Type: Poster Session
Part of Session: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Location/Room: OCCC - West Halls B3-B4

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. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. 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 Healthcare Communications

audrafriis@sambrown.com

(917) 519-9577

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were the key efficacy results for ALXO's evorpacept plus R2 at ASH 2025?

CR 92%, PR 8%, ORR 100%, one‑year PFS 91%, one‑year OS 100% in 24 frontline iNHL patients.

How many patients were enrolled in the ALXO investigator‑sponsored Phase 2 iNHL trial?

A total of 24 previously untreated iNHL patients were enrolled (14 follicular, 10 marginal zone).

Did the evorpacept plus R2 regimen meet its primary endpoint in the ALXO study?

Yes; the trial met the primary objective with a best complete response rate above the prespecified 80% threshold.

What safety or tolerability information was reported for ALXO's combination therapy?

Investigators reported the addition of evorpacept to R2 was well tolerated as a frontline non‑chemotherapy regimen.

Will MRD and long‑term durability be evaluated for ALXO's evorpacept data?

Yes; longer follow‑up and evaluation of minimal residual disease (MRD) from the study were identified as next steps.

Where and when was ALXO's evorpacept Phase 2 poster presented?

The poster (Presentation ID 3571) was presented at ASH Annual Meeting 2025 on December 7, 2025, during the poster session in Orlando.