On March 2, 2026 Artios Pharma Limited ("Artios"), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, reported data from a randomized Phase 2a clinical study (NCT04657068). The trial evaluated Artios’ lead candidate, alnodesertib, in combination with gemcitabine versus gemcitabine alone in patients with platinum-resistant high-grade serous ovarian carcinoma (HGSOC). The results were presented by Principal Investigator Antonio Gonzalez-Martin, MD, PhD, Director of the Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra, in a poster session at the 27th European Society of Gynaecological Oncology (ESGO) Annual Meeting held in Copenhagen, Denmark, from February 26-28, 2026.
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Alnodesertib is a highly potent, oral, selective inhibitor of the protein kinase ataxia telangiectasia and Rad3-related (ATR). ATR is a key regulator of the cellular response to replication stress, which can occur endogenously or exogenously, for example, via chemotherapy. Multiple cancer types, including HGSOC, are characterized by high endogenous replication stress and rely on ATR to repair damaged DNA before cancer cells progress through the cell cycle. Combining the ATR inhibitor alnodesertib with the DNA-damaging agent gemcitabine amplifies replication stress and has demonstrated additional and more durable clinical benefit.
"This randomized Phase 2a study evaluating a low dose of alnodesertib and the labelled dose of gemcitabine in platinum-resistant ovarian cancer achieved the primary endpoint of progression-free survival, further establishing proof-of-concept in our differentiated approach of inhibiting ATR in tumors with high replication stress," said Ian Smith, Chief Medical Officer of Artios. "These data support further investigation of alnodesertib plus DNA-damaging agents, which we are currently evaluating at higher doses of alnodesertib plus low dose irinotecan in patients with colorectal and pancreatic cancer."
Highlights of clinical data presented at ESGO 2026:
In the Phase 2a study, 64 patients with platinum-resistant HGSOC were randomized 1:1 to receive a low dose of alnodesertib plus standard-of-care gemcitabine or the same dose of gemcitabine alone, stratified by platinum-free interval. The gemcitabine treatment with or without alnodesertib was administered during a 21-day cycle at the recommended phase 2 dose, which included alnodesertib (50mg) on days 2 – 4 and 9 – 11, and gemcitabine (800mg/m²) on days 1 and 8.
Combining a low dose of alnodesertib with gemcitabine was statistically significant (p<0.1, one-sided test) and improved progression-free survival (PFS) with a 29% reduction in the risk of progression or death compared with gemcitabine alone
6-month PFS rate was 34% with low dose alnodesertib plus gemcitabine compared to 23% with gemcitabine alone
13 patients (41%) initially randomized to gemcitabine alone were crossed over to the combination with low dose alnodesertib, following disease progression; several patients experienced longer and clinically relevant disease control when low dose alnodesertib was added to the treatment regimen
Key secondary endpoints of overall response rate and overall survival were comparable in both treatment arms, with overall survival analysis confounded by a 41% cross-over rate
The most frequent adverse events were asthenia, pyrexia, and hematologic and gastrointestinal toxicities
Overall rates of grade ≥3 adverse events were similar in both arms (66% with low dose alnodesertib plus gemcitabine vs 63% with gemcitabine alone), although grade ≥3 anemia and thrombocytopenia were more common with the combination
No treatment‑related deaths or cases of febrile neutropenia were reported in either arm of the study
"The encouraging clinical signals we observed in patients when low dose alnodesertib was added to gemcitabine suggest that this approach warrants further evaluation," said Principal Investigator, Antonio Gonzalez-Martin, MD, PhD, Director of the Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra. "With approximately 70% of patients with ovarian cancer eventually relapsing following platinum-based chemotherapy, there is a high unmet need for promising new therapies like alnodesertib to improve clinical outcomes in platinum-resistant HGSOC and other tumors with high replication stress."
About alnodesertib
Alnodesertib, formerly known as ART0380, is a potential first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). It is designed to be used in combination with DNA‑damaging agents and is being evaluated across multiple tumor types characterized by high endogenous replication stress. Artios’ differentiated approach combines alnodesertib with low‑dose irinotecan to exploit replication stress in cancers such as ATM protein–deficient metastatic colorectal and pancreatic cancer, and other chemotherapies, like gemcitabine, to address platinum-resistant high-grade serous ovarian cancer (HGSOC).
(Press release, Artios Pharma, MAR 2, 2026, View Source [SID1234663169])