Dana-Farber to Present Phase 3 Lung Cancer Data at ESMO

Dana-Farber Cancer Institute researchers will present the primary analysis of the phase 3 DeLLphi-305 trial in extensive-stage small cell lung cancer at the Presidential Symposium of the 2026 European Society for Medical Oncology Congress in Madrid. Jacob Sands, MD, will present the study on October 24, comparing first-line maintenance treatment with tarlatamab plus durvalumab against durvalumab alone after initial treatment with durvalumab, platinum chemotherapy and etoposide. The release announces the presentation but does not provide numerical efficacy or safety results from the primary analysis. The congress will take place from October 23 through October 27, with presentations available both in person and online.

DeLLphi-305 is designed to evaluate whether adding tarlatamab to durvalumab improves maintenance therapy for patients with extensive-stage small cell lung cancer whose first-line regimen has included durvalumab, platinum and etoposide. Sands is also scheduled to participate in ESMO Press Briefing I on October 24. The Dana-Farber release does not describe the size of the trial, the number of participants, the effect estimates, confidence intervals, safety outcomes or secondary endpoints in DeLLphi-305. Accordingly, the available evidence establishes the design and scheduled presentation of the phase 3 primary analysis, not the magnitude of any treatment benefit or clinical effect.

The wider Dana-Farber program includes studies in prostate, breast, kidney and endometrial cancers, along with special sessions devoted to cancer vaccines. Mary-Ellen Taplin, MD, is the senior author of a Proteus substudy comparing perioperative apalutamide plus androgen deprivation therapy, radical prostatectomy and pelvic lymph node dissection against radical prostatectomy plus pelvic lymph node dissection alone in patients with high-risk localized or locally advanced prostate cancer. The abstract is scheduled for a proffered-paper session on October 24. Separately, Joyce Liu, MD, MPH, will serve as discussant for the phase 3 TroFuse-005/ENGOT-en23/GOG-3095 study of sacituzumab tirumotecan in previously treated advanced or recurrent endometrial cancer during Presidential Symposium III on October 26.

Two Dana-Farber experts will lead ESMO sessions about cancer vaccines. Patrick Ott, MD, PhD, is scheduled to present “Personalizing vaccines using peptides, DNA, mRNA and more” in a melanoma special symposium and “Personalized Cancer Vaccines” in an education session. Toni Choueiri, MD, will address what medical oncologists should know about messenger RNA vaccines from the perspective of a medical oncologist. These sessions are scheduled as educational and research presentations rather than clinical efficacy reports, and the announcement does not provide trial results for the vaccine research discussed in them.

A randomized phase 2 study reported a progression-free survival advantage for an investigational selective CDK4 inhibitor in patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer whose disease had progressed after CDK4/6 inhibitors. The open-label, multicenter FOURLIGHT-1 study enrolled 263 patients and compared atirmociclib plus endocrine therapy with the standard of care. Antonio Giordano, MD, PhD, reported that median progression-free survival was 9.4 months in the atirmociclib-plus-endocrine-therapy group and 6.6 months in the standard-of-care group. The release describes atirmociclib as well tolerated and reports improved progression-free survival in patients with both visceral and nonvisceral metastases, while identifying further study as the next step for the investigational combination.

The breast cancer program also includes retrospective exploratory biomarker analyses from evERA Breast Cancer, a phase 3 trial that assessed giredestrant plus everolimus against standard care in 373 patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with CDK4/6 inhibitors. Giredestrant is a selective estrogen receptor degrader and full antagonist. The exploratory analysis examined genomic alterations, the number and types of ESR1 mutations, and circulating tumor DNA. Sara Tolaney, MD, MPH, reported that the combination extended progression-free survival in subgroups with alterations including TP53, GATA3 and RB1, as well as among patients with multiple ESR1 mutations or higher circulating tumor DNA levels. These were retrospective subgroup observations within the phase 3 trial, not a new randomized comparison or evidence that the benefit was confined to a single biomarker group.

A separate phase 3 trial found that neither of two experimental additions improved efficacy over the established regimen for untreated advanced clear cell renal cell carcinoma. The open-label LITESPARK-012 trial randomized 1,688 patients to pembrolizumab plus lenvatinib, the same regimen plus the HIF-2α inhibitor belzutifan, or pembrolizumab plus lenvatinib plus MK-1308A, a coformulation of the CTLA-4 inhibitor quavonlimab and pembrolizumab. Choueiri reported that neither triplet regimen improved efficacy in the first-line population. Over 108 weeks, withdrawal from the regimen occurred in 51.6% of patients assigned to belzutifan, 51.4% assigned to MK-1308A and 36.2% assigned to standard care, showing more treatment withdrawals in both experimental arms.

LITESPARK-012 therefore did not support either experimental addition to pembrolizumab and lenvatinib in the studied population, while also showing greater discontinuation with the added agents. The release says the trial did not meet its objectives but that the findings may inform the design of future studies in advanced renal cell carcinoma. The result contrasts the absence of an efficacy improvement with the higher treatment-withdrawal percentages in both experimental arms. It adds randomized evidence about the two tested combinations in previously untreated advanced clear cell renal cell carcinoma without establishing a new first-line treatment approach.

An analysis of the phase 3 COSMIC-313 trial indicates that changes in plasma kidney injury molecule-1, or KIM-1, were associated with differences in the likely benefit from first-line immunotherapy with or without cabozantinib. COSMIC-313 previously found improved progression-free survival with nivolumab plus ipilimumab followed by cabozantinib compared with immunotherapy alone in advanced clear cell renal cell carcinoma. In the new analysis, reductions in KIM-1 were found in patients with immune-inflamed tumors that might be more responsive to immunotherapy, whereas patients without KIM-1 reductions more often had immune-depleted tumors. Wenxin Xu, MD, and colleagues used pretreatment tumor transcriptomics to create a model that predicted KIM-1 response after immunotherapy. Patients predicted to have a poor KIM-1 response appeared to benefit more from adding cabozantinib.

The KIM-1 analysis remains a biomarker assessment of randomized trial data rather than proof that a clinical test should guide treatment selection. The release does not report the model’s accuracy, performance measures, confidence intervals or validation in an independent cohort. Taken together, the announced ESMO presentations span a phase 3 small cell lung cancer primary analysis, a randomized phase 2 breast cancer study, exploratory breast cancer biomarker analyses, a negative phase 3 kidney cancer trial, a renal cancer biomarker model and sessions on personalized and messenger RNA cancer vaccines. The detailed findings disclosed in the release come from the breast and kidney studies; for DeLLphi-305, the available information concerns the trial design, population and scheduled presentation rather than the primary outcome results.

Subject of Research: Dana-Farber clinical and biomarker studies in lung, breast, kidney, prostate and endometrial cancer scheduled for the 2026 ESMO Congress.

Article Title: Dana-Farber presents Phase 3 lung cancer data in ESMO Presidential Symposium

Article References: Dana-Farber presents Phase 3 lung cancer data in ESMO Presidential Symposium. Original publication (Bibliographic details unavailable.)

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Keywords: ESMO 2026, small cell lung cancer, DeLLphi-305, tarlatamab, breast cancer, atirmociclib, renal cell carcinoma, KIM-1 biomarker, cancer vaccines, prostate cancer, Dana-Farber, presents