ESMO 2026 多项数据改写胰腺癌与前列腺癌治疗格局
ESMO26: Clinical progress shifts a historically difficult pancreatic cancer landscape
ESMO 2026 于 10 月 23 日至 27 日在马德里召开,多项研究公布数据。
汇总 ESMO 2026 多项数据,呈现胰腺癌与前列腺癌在长期随访和联合方案上的进展。
Pancreatic cancer has historically presented a poor clinical outlook, offering patients few effective therapeutic options. Because the disease rarely causes early symptoms, diagnoses typically occur at advanced stages, where a dense, fibrous stroma surrounds tumours and shields them from systemic therapy.
Against this backdrop, data from Revolution Medicines Phase III RASolute 302 trial (NCT06625320) showed a near doubling of overall survival (OS) in patients treated with the daily oral RAS(ON) inhibitor Rasonque (daraxonrasib). The US Food and Drug Administration (FDA) approved the drug in August 2026.
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The data showed a median overall survival (OS) of 13.2 months in the investigational arm, compared with 6.7 months in the standard-of-care (SOC) arm.
Although a substantial amount of data has already been released, Revolution presented further findings at the 2026 European Society for Medical Oncology (ESMO) Congress.
Trial investigator Dr Zev Wainberg, a professor of medicine and gastrointestinal medical oncology at UCLA, presented a subgroup analysis stratified by tumour mutational status. For the most common mutation, RAS G12D, which accounted for 43.2% of patients in the study, the overall response rate (ORR) was 32%, compared to 11% in the placebo cohort. In RAS G12V, ORR was 24% compared to 9% in the placebo cohort. OS throughout all of the mutation subgroups favoured Rasonque.
Long-term survival benefit with abiraterone combinations
Adding abiraterone to standard treatment provides a lasting survival benefit for men whose prostate cancer has already spread at diagnosis, reinforcing the value of early treatment intensification.
Data from almost eight years of follow-up in the academically led Phase III PEACE-1 trial (NCT01957436) found that for men with de novo metastatic castration-sensitive prostate cancer, the risk of death was reduced by 25% when adding abiraterone to standard of care (SOC). Median OS was 6.1 years with abiraterone versus 4.6 years without it.
The PEACE-1 trial included 1,173 patients who all received SOC of an ADT, with or without docetaxel chemotherapy. They were then randomly assigned to receive no additional treatment, abiraterone plus prednisone, radiotherapy to the prostate, or both abiraterone plus prednisone and radiotherapy.
Overall, 57% had high-volume disease, indicating more extensive cancer spread. An earlier analysis showed that adding abiraterone to standard of care improved overall survival.
Among the 710 men who received ADT plus docetaxel, adding abiraterone plus prednisone reduced the risk of death by 32%.
In men with high-volume disease, median survival was 4.6 years with triplet therapy versus 3.5 years with doublet therapy, and almost twice as many were alive at eight years (38% vs 20%).
In men with low-volume disease, median survival was 7.8 years with triplet therapy versus 6.2 years with doublet therapy, although this difference was not statistically significant on its own.
“There is a major survival benefit, with almost two years of additional life for patients receiving the three treatments, which is of course highly significant,” said lead author Dr Karim Fizazi, Centre Oscar Lambret, Lille, France. “In our opinion, this makes this triplet treatment a strong SOC for these patients. Most clinical trials, especially when led by pharma companies, tend to stop their follow-up early. This long-term analysis demonstrated that the survival benefit becomes greater with time: for instance, in men with multiple metastases at diagnosis, there are almost twice as many long-term survivors with triplet therapy.”
Syncromune’s cancer vaccine maintains no disease recurrence
Another notable pancreatic cancer readout came from Syncromune’s Phase I trial (NCT05544227) of SV-102, its SYNC-T Therapy in situ personalised cancer vaccine. The therapy freezes a portion of the tumour to release tumour-specific antigens, then delivers a fixed-dose drug cocktail directly into the treatment site to stimulate a systemic antitumor immune response.
Data showed an 87% ORR and a 40% complete response rate (CRR) in patients with metastatic castration-resistant prostate cancer (mCRPC).
Speaking to Clinical Trials Arena at ESMO, Dr Charles Link, executive chairman, and chief innovation officer, said that of the six patients who had confirmed CRR in the study, as they approach the three-year mark, they continue to have no disease recurrence.
Syncromune has now commenced recruitment for a Phase IIa study (NCT06533644) which is aiming to enrol 36 patients.
Tango Therapeutics combo improves PFS
Also making headlines at ESMO 2026 is Tango Therapeutics, which previewed its Phase I/II study of vopimetostat, an investigational PRMT5 inhibitor with first- and best-in-class potential, in combination with Revolution Medicines’ Rasonque in patients with MTAP-deleted and RAS-mutant metastatic pancreatic ductal adenocarcinoma.
As of the data cutoff date of 20 August 20, 2026, the study demonstrated an 82% ORR, with median PFS having not yet been reached. The cutoff saw a nine-month PFS rate of 88% in 22 patients with 2L/3L MTAP-deleted/RAS-mutant pancreatic ductal adenocarcinoma who were efficacy-evaluable.
Dr Malte Peters, CEO and president of Tango Therapeutics, said: “It is encouraging to see that the clinical activity and tolerability observed in our initial June 2026 dataset has been confirmed with longer follow-up and in a larger patient population, affirming our belief that the response rate and durability observed with vopimetostat plus Rasonque surpass any published PDAC datasets, even in front-line settings.”
These data prompted Tango to plan a registrational Phase III trial evaluating vopimetostat with Rasonque as a first-line treatment for MTAP-deleted pancreatic cancer, with initiation expected in the first half of 2027.
GlobalData valued the pancreatic cancer market in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, China, and Japan) at $2.2bn in 2024 and expects the market to increase to $10.2bn by 2034. GlobalData is the parent company of Clinical Trials Arena.
来源:Clinical Trials Arena · clinicaltrialsarena.com