ALX Oncology (ALXO) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Company overview and approach

• Focuses on CD47 blockade, separating the "don't eat me" and "eat me" signals to enhance efficacy and safety in cancer therapy.

• Employs combination strategies with anticancer antibodies, ADCs, and checkpoint inhibitors to drive unique therapeutic effects.

• Currently has nine ongoing clinical studies across solid and hematologic malignancies.

Key clinical data and learnings

• ASPEN-06, a randomized study in second- and third-line gastric cancer, showed a 40% response rate vs. 26% for control, with durable responses over 15 months.

• Safety profile in combinations is strong, supporting further development.

• Fresh biopsy and strong HER2 expression are critical for optimal efficacy, influencing future trial design.

• Plans to enrich future studies for HER2-positive patients, possibly mandating fresh biopsies.

Development plans and regulatory strategy

• Awaiting mature PFS data, expected to be shared in the first half of next year.

• A PFS delta of 2+ months is considered meaningful for regulatory discussions.

• Committed to moving into phase III for gastric cancer, with accelerated approval still a possibility depending on data maturity.

• Exploring expansion into other solid tumors such as colorectal, head and neck, and breast cancer.