Onco-Summaries: Daily Oncology Updates at a Glance
Updated: Sep 30
28/09/2026
Evorpacept demonstrates efficacy benefit in HER2-retained/high-CD47 gastric cancer subsets, in Phase 2 ASPEN-06 study; ALX will not pursue a US registrational Phase 3 study, evaluates partnership opportunities (Ref)
ALX Oncology announced the publication of its Phase 2 ASPEN-06 study results in Nature Medicine, highlighting clinically meaningful activity of evorpacept (anti-CD47) in combination with trastuzumab, ramucirumab, and paclitaxel for previously treated HER2-positive gastric/gastroesophageal junction cancer
The evorpacept-containing regimen achieved a higher objective response rate (ORR) compared with the control arm
The greatest benefit was observed in patients with retained HER2 positivity and high CD47 expression, with improvements in ORR
Endpoint | Evorpacept Arm | Comparator Arm (TRP alone) | Key Finding |
ORR (Overall Population) | 40.3% | 26.6% | Improved overall response rate versus standard treatment |
ORR (Retained HER2+) | 48.9% | 25.0% | Nearly doubled response rate in patients retaining HER2 expression |
ORR (HER2+ / High CD47) | 63.6% | 23.1% | Greatest treatment benefit observed in biomarker-selected patients |
Median PFS (HER2+ / High CD47), months | 19.5 | 7.0 | ~12.5-month improvement in progression-free survival |
Median DOR (HER2+ / High CD47), months | 25.5 | 8.4 | Responses were substantially more durable with evorpacept |
The findings support CD47 expression as a potential predictive biomarker and reinforce a biomarker-guided development strategy for evorpacept
Despite the positive Phase 2 data, ALX does not plan to advance a Phase 3 registrational study in gastric cancer and may seek partnership opportunities for further development in this indication
The company remains focused on its ongoing Phase 2 ASPEN-09-Breast trial evaluating evorpacept in HER2-positive metastatic breast cancer, with topline data expected in mid-2027
Innovent expands Phase 3 MarsLight-11 trial of IBI363/TAK-928 in NSCLC (Ref)
Innovent Biologics announced the expansion of its global Phase 3 MarsLight-11 trial evaluating IBI363/TAK-928, an alpha-biased IL-2/PD-1 bispecific fusion protein, to include patients with non-squamous non-small cell lung cancer (NSCLC) in addition to the previously enrolled squamous NSCLC population.
This broadens the potential registrational opportunity for the program in patients who have progressed following platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.
The study will now contain two independent substudies comparing IBI363 monotherapy against docetaxel in patients with unresectable, locally advanced, or metastatic NSCLC whose disease has progressed after prior chemotherapy and immunotherapy
Squamous NSCLC
Non-squamous NSCLC
AstraZeneca invests $2B in Summit Therapeutics to advance ivonescimab-ADC combination strategy across multiple cancers (Ref)
AstraZeneca announced strategic equity investment and clinical collaboration with Summit Therapeutics which aims to accelerate the development of Akeso & Summit Therapeutics' ivonescimab (PD-1 x VEGF BsAb) -based cancer combination therapies, leveraging AstraZeneca’s ADC portfolio to potentially enhance treatment efficacy across multiple tumor types. The partnership includes a $2 billion equity investment and plans for a broad global clinical development program
AstraZeneca will invest $2 billion in Summit Therapeutics, acquiring preferred shares representing approximately 12% of Summit’s outstanding common stock.
The companies will initiate clinical studies evaluating sonesitatug vedotin (Sone-Ve), AstraZeneca’s CLDN18.2-targeted ADC, in combination with ivonescimab, in gastrointestinal cancers.
The collaboration is supported by a broader memorandum of understanding to explore additional combinations of ivonescimab with AstraZeneca’s oncology pipeline, including other ADC assets.
The strategic rationale is to combine ADC-driven tumor cell killing with dual PD-1 and VEGF pathway inhibition, with the goal of improving anti-tumor activity and overcoming resistance mechanisms.
AstraZeneca highlighted recent positive Phase III data for Sone-Ve in CLDN18.2-positive advanced gastric cancer, supporting expanded development opportunities for the asset
Teva Receives US FDA Approval for DEGEVMA, a biosimilar to Xgeva (denosumab) (Ref)
Teva Pharmaceutical Industries announced that the US FDA has approved DEGEVMA (denosumab-adet), a biosimilar to Xgeva (denosumab; anti-RANKL), expanding its biosimilar portfolio in oncology supportive care
DEGEVMA is approved for the same indications as Xgeva, including prevention of skeletal-related events in patients with bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.
The approval was supported by analytical, pharmacokinetic, and clinical data demonstrating biosimilarity to Xgeva, consistent with the FDA's totality-of-evidence approach.
DEGEVMA represents Teva's second FDA-approved biosimilar in 2026 and complements PONLIMSI, Teva's biosimilar to Prolia, creating a comprehensive U.S. denosumab biosimilar portfolio.
Teva expects to launch DEGEVMA alongside PONLIMSI in the US, further enhancing access to lower-cost denosumab treatment options.
The approval reinforces Teva's ongoing biosimilars expansion strategy and strengthens its position in oncology and bone health markets.
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