On April 9, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial ("IST") of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL (Press release, ALX Oncology, APR 9, 2024, View Source [SID1234641922]). The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting.

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The clinical trial enrolled a total of 20 patients with indolent (n=18) and aggressive (n=2) R/R B-NHL where all patients had received prior rituximab and 72% had received prior chemoimmunotherapy. Patients received evorpacept 30 mg/kg Q2W (n=3) or 60 mg/kg Q4W (n=17) in combination with standard R2 treatment. The regimen was well tolerated, and there were no dose-limiting toxicities. The maximum administered dose for evorpacept was 60 mg/kg Q4W. The most common adverse events due to any cause were fatigue, ALT increase, anemia, and AST increase, all of which were mostly low grade. There were no reported treatment-related deaths on study. Patients with indolent R/R B-NHL (n=18) had a best ORR of 94% and a CRR of 83%. The median duration of response was not reached. The AUGMENT Phase 3 clinical trial1, a benchmark study in a similar patient population, reported an ORR of 78% and a CRR of 34% with R2 alone.

"While standard frontline treatments have shown benefit in the indolent B-NHL setting, many patients are likely to see their disease progress after initial treatment," said Paolo Strati, M.D., the trial’s lead investigator and Assistant Professor of Lymphoma-Myeloma at The University of Texas MD Anderson Cancer Center. "We are pleased evorpacept in combination with R2 demonstrated a favorable safety profile and encouraging response in this patient population. These data further illustrate the importance of exploring novel combinations with evorpacept to elicit anti-tumor activity by way of the innate immune response. We are excited to build upon these preliminary results as we evaluate the evorpacept-R2 combination in the ongoing Phase 2 portion of this clinical trial in patients with previously untreated indolent B-NHL."

"These initial results reinforce evorpacept’s differentiated drug design that has resulted in anti-cancer activity while minimizing hematologic toxicities inherent to other CD47 blocking agents," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "Furthermore, the findings presented today build upon the promising data reported from the ASPEN-01 Phase 1 clinical trial of evorpacept in combination with rituximab in R/R NHL2. We look forward to applying these and other clinical trial data to inform new evorpacept combinations in our expanding pipeline. We would like to thank the patients and research team for conducting this important clinical trial."

Details of the Oral Presentation at the 2024 AACR (Free AACR Whitepaper) Annual Meeting are as follows:

A Phase 1 investigator-initiated trial of evorpacept (ALX148), lenalidomide and rituximab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma
Session Title: Clinical Trials Minisymposium / Novel Agents and Emerging Therapeutic Strategies
Presentation Date and Time: Tuesday, April 9, 2024, 2:50 PM – 3:00 PM PT
Abstract: CT037 (full abstract is available online here)

The presentation is available on the publications page of the ALX Oncology website here.

About the Phase 1/2 IST Investigating Evorpacept Combination to R2 in NHL

The Phase 1/2 IST is an ongoing, open-label, single arm clinical trial designed to evaluate the safety, tolerability, and efficacy of evorpacept, otherwise known as ALX148, in combination with R2 in patients with R/R B-cell NHL (both indolent and aggressive) histology. Patient enrollment is currently open to the Phase 2 portion of the study evaluating patients with previously untreated indolent B-NHL (NCT05025800). The study is sponsored and conducted by MD Anderson Cancer Center.

About Non-Hodgkin Lymphoma

Approximately 500,000 people worldwide are diagnosed with NHL each year. In the U.S., NHL is the seventh most common type of cancer, and over 80,000 newly cases of NHL were estimated in 20233. NHL can be divided into two groups according to how the disease progresses: indolent and aggressive lymphomas. The most prevalent form of NHL, accounting for about 32% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma. Follicular lymphoma is the most common subtype of indolent NHL and accounts for about 17% of newly diagnosed NHL cases. Indolent B-cell lymphomas tend to grow more slowly and may have fewer signs and symptoms than aggressive lymphomas when first diagnosed. For patients with indolent B-cell lymphoma, current first-line treatments include radiotherapy, anti-CD20 monoclonal antibodies, and chemoimmunotherapy. Despite advances in treatment, follicular lymphoma remains a significant cause of death.