We use cookies to improve your experience, analyze site usage, and show relevant ads. Go to our Privacy Policy for details.
The call conveyed meaningful, reproducible efficacy signals for evorpacept combinations—especially in CD47-high, centrally confirmed HER2-positive patients—with durable responses across independent studies, a large evorpacept safety database, progressing second program (ALX2004), and strengthened corporate resources. However, the clinical findings are preliminary given small exploratory cohorts, CD47 assay/cutoff uncertainty, discordant HER2 testing, and anticipated need for a registrational trial, which introduces execution and regulatory risk. Overall, momentum and positive clinical signals outweigh the limitations, but important validation and prospective biomarker work remain.
Management reiterated both programs are on track: ASPEN‑09 will enroll up to 120 patients (interim top‑line from ~80 patients expected mid‑2027) with a primary endpoint of ORR in the CD47‑overexpressing subset and the company aims to be ready for registrational studies by end‑2027; ALX2004 dose escalation (1 → 2 → 4 mg/kg cohorts) is progressing with an initial safety readout planned H2‑2026. They highlighted recent efficacy metrics: evorpacept+zanidatamab exploratory cohort (n=24, median 5 prior lines, all prior T‑DxD) showed overall ORR 33%, ORR 60% in 10 centrally confirmed HER2+ patients, median DOR ~20 months, median PFS 3.6 months overall (8.3 months in centrally HER2+), and in the centrally HER2+/CD47‑high (≥20% IHC) subgroup all 5 patients responded with median PFS ≈22 months; these findings were consistent with ASPEN‑06 (n=127) where evorpacept arm ITT ORR was 41%, >49% in retained HER2, 65% in CD47+ patients, median PFS 18.4 months, HR 0.39 in the CD47 subset and median DOR 25.5 months. They also noted a clinical safety database of >800 evorpacept‑treated patients, zanidatamab dosing at 1,200 mg (<70 kg)/1,600 mg (≥70 kg) with evorpacept at 20–30 mg/kg IV q2w, CD47 prevalence around ~50% (gastric 45–57% reported), an estimated ~20,000 addressable HER2+/CD47‑high patients representing a $2–4B US/EU5/Japan market, and that a February financing strengthens the balance sheet to fund milestones over the next 1–2 years.
Phase Ib/II exploratory results in heavily pretreated HER2-positive metastatic breast cancer (n=24) showed an overall confirmed objective response rate (ORR) of 33% (24 patients). In the 10 patients with centrally confirmed HER2-positive disease the ORR was 60%.
Using a retrospective cutoff of CD47 >=20%, 5 centrally confirmed HER2-positive patients were CD47-high and all 5 achieved a confirmed response (100% ORR). Median duration of response (DOR) in responders was ~20 months and median progression-free survival (PFS) in the CD47-high group was ~22 months versus 3.4 months for CD47-low.
Independent data from ASPEN-06 (HER2-positive gastric randomized Phase II) showed parallel trends: ITT response rate ~41%, higher response in HER2-retained patients (~49%+), and 65% ORR in CD47-overexpressing patients. Duration of response in the gastric CD47-high subset was ~25.5 months and median PFS ~18.4 months with hazard ratio ~0.39 in that subset, reinforcing reproducibility of the CD47 signal.
Responders across studies exhibited long-lasting benefit with median DORs around 20 months (breast study ~20.2 months; gastric study ~25.5 months), indicating durability consistent with an immuno-oncology mechanism.
Clinical safety database exceeds 800 evorpacept-treated patients. Evorpacept is engineered without an active Fc domain to avoid macrophage activation on healthy cells, aiming to mitigate on-target hematologic toxicity associated with earlier CD47 inhibitors.
ALX2004 (EGFR-targeted ADC) is advancing through dose escalation (reported escalation up to 4 mg/kg) with enrollment progressing and an initial safety readout planned in the second half of 2026.
Q1 accomplishments included completion of key hires (addition of Chief Development/COO), a financing in February anchored by strong investors that strengthened the balance sheet, and enrollment progress on ASPEN-09 (Phase II breast study planned to read out ~80 patients mid-2027).
Greetings, and welcome to the ALX Oncology First Quarter 2026 Financial Results Conference and webcast. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Jason Lettmann, CEO. Please go ahead, sir.
Thanks, everyone, and welcome to our Q1 2026 results. I really appreciate you all spending time with us this morning and are looking forward to sharing these updates with you. On Slide 2 and before we start our presentation as housekeeping, here are our forward-looking statements for your review. On Slide 3, here's the agenda and plan for today. We're going to be providing an update on our key accomplishments in the first quarter of 2026. Most notably, we are very excited to share with you the data set that was presented yesterday in Munich at ESMO Breast 2026 from the analysis of our trial evaluating evorpacept and zanidatamab, which clearly showed again that CD47 expression is a key predictive biomarker for increasing durable clinical response in heavily pretreated HER2-positive patients. This further validates the results we saw with Evo and HER2-positive gastric cancer from our ASPEN-6 trial. We are also very excited today to be joined by Dr.
Sara Hurvitz from the Fred Hutch Cancer Center at the University of Washington, who is a well-recognized expert in metastatic breast cancer. She will be presenting the ESMO breast data in detail and also share her views on evorpacept's significant potential within the current treatment paradigm for HER2-positive metastatic breast cancer. Our CMO, Barb Klencke, will th...