Cancer Cells destroyed by oncogenic virus. Image from Shutterstock
As in previous years, the 2025 ASCO Annual Meeting showcased a strong portfolio of practice-changing data across a wide range of tumor types. Combination therapies remain a central theme, continuing to drive meaningful improvements in clinical outcomes. These benefits are increasingly balanced by evolving strategies for managing adverse events, underscoring the field’s commitment to both efficacy and tolerability. Novel modalities and next-generation treatments are raising the bar for what is possible with cancer treatment. While already approved therapies are being proven in new expansion opportunities, emphasizing the consistent innovation and curiosity that drives new breakthroughs in cancer treatment.
Redefining standards in lung cancer care: the next chapter
ASCO 2025 saw major shifts within the lung cancer landscape, with potentially practice-changing data being presented, particularly in SCLC, which has not seen a shift of this magnitude in several years. The DeLLphi-304 study provided a look at the remarkable data supporting Imdelltra, showcasing a median overall survival (mOS) of 13.6 months vs 8.3 months for standard of care (SoC) (HR: 0.6) and a median progression-free survival (mPFS) of 4.2 months vs 3.7 months for SoC (HR: 0.71). This is the first Phase 3 study to demonstrate a significant OS improvement, affirming tarlatamab as a new standard of care in second-line and beyond (2L+) extensive-stage (ES)-SCLC, an aggressive disease with high unmet need. Furthermore, this underscores Imdelltra as a first-in-class DLL3-targeting immunotherapy for SCLC and offers a long-awaited breakthrough for a notoriously challenging cancer type.
Data from the IMforte trial highlighted another notable advancement in SCLC management, with lurbinectedin + atezolizumab demonstrating an mOS of 13.2 months (vs 10.6 months with atezolizumab alone; HR: 0.73) and an mPFS of 5.4 months (vs 2.1 months with atezolizumab alone; HR: 0.54). With the survival benefit confirmed, lurbinectedin is expected to move up the treatment algorithm as a maintenance strategy in combination with immunotherapy, the current standard, in the extensive-stage SCLC setting. As such, this represents a truly practice-changing development and establishes a new standard of care in the first-line (1L) ES-SCLC maintenance setting.
Transformative outcomes in gastrointestinal (GI) cancers
Several advancements within GI were made during the conference, redefining the standards of care. Data from AstraZeneca’s MATTERHORN trial, which showed a 29% improvement in EFS with durvalumab + FLOT compared to PBO + FLOT (HR 0.71), represented a milestone for early line gastric cancer. In addition, data showed that mOS has not yet been reached for durvalumab + FLOT, while mOS was 47.2 months with PBO + FLOT (HR = 0.78). With this, it is likely that perioperative chemoimmunotherapy will become the SoC for resectable G/GEJ cancer. Furthermore, the study intentionally sought to evaluate the FLOT regimen globally and showcases the value in reviewing the data under the lens of geographic variation in disease by tumor type, histology, and biomarker characteristics.
Following its December 2024 accelerated approval, Pfizer also presented additional data from the BREAKWATER trial, showing a mOS of 30.3 months (vs 15.1 months in SoC) and a mPFS of 12.8 months (vs 7.1 months in SoC). This data further elucidates the survival benefits of the encorafenib plus cetuximab regimen with mFOLFOX6 for patients with BRAF V600E-mutated metastatic CRC, thus reinforcing the combination regimen’s role in this difficult to treat population.
Data from the ATOMIC trial, which showed a 3-year DFS was 86.4% in the atezolizumab combination arm (vs 76.6% in the mFOLFOX6 arm, HR: 0.50), were also deemed “practice changing” for patients with dMMR colon cancer. The study is a step forward to bringing immunotherapy into the adjuvant setting in colon cancer and has the potential to become the standard of care for these earlier line patients. Furthermore, with potential to continue atezolizumab monotherapy, it provides a potential chemo-free regimen for these patients.
The role of biomarkers in genitourinary and reproductive cancer treatments
As with genitourinary and reproductive cancers, combination regimens seek to improve outcomes in patients where there has been limited innovation in previous years. In prostate cancer, the AMPLITUDE trial demonstrated that niraparib + AAP significantly improved rPFS, with median rPFS not being reached after ~2.5 years of follow-up (vs 29.5 months for PBO + AAP; HR: 0.63). rPFS benefit was especially pronounced in BRCAm patients (HR:0.52). This trial moves up an already well-known combination earlier in the course of disease, positioning it as a potential new standard-of-care for the patients with deleterious germline or somatic HRR Gene-Mutated mHSPC.
While in platinum-resistant ovarian cancer, the ROSELLA trial showed a mOS of 16 months (vs 11.5 months; HR: 0.69) and a mPFS of 6.5 (vs 5.5 months; HR 0.70) in favor of relacorilant, which aside from its efficacy showed no new safety signals. Relacorilant + nab-paclitaxel is the first treatment regimen to demonstrate a PFS and OS benefit in patients with 2-4L PROC without the need for biomarker selection. This positions relacorilant as a potentially robust add-on therapy to the existing SoC without affecting the risk-benefit, all while improving clinical outcomes, resulting in a potentially new treatment paradigm.
Expanding possibilities through innovation in hemato-oncology
ASCO 2025 also shone a light on advancements within hemato-oncology. In relapsed/refractory B-cell lymphoma, Gilead and Kite Pharma’s KITE-363, which targets both CD19 and CD20, showed a complete response (CR) rate of 78% in CAR-naive patients, with no dose-limiting toxicities (DLTs) observed in the Phase 1 trial. The median duration of response (DOR) was not yet reached at the time of the analysis. With increasing competition within B-cell malignancy therapeutics, DOR will become a key differentiator for therapies like KITE-363. Future safety data and a demonstration of scalability may allow the broad adoption of this dual CAR-T, paving the way for an innovative treatment methodology for these patients.
In r/r NPM1m AML, the pivotal KOMET-001 trial met its primary endpoint, showing a complete remission with full or partial hematologic recovery of 25% in the pooled phase 1b/2 trial. Additional trial data demonstrated that the mean duration of overall response was 4.6 months, and the restricted mean duration of overall response was 6.5 months. With no currently available FDA approved therapies for this patient segment, this data positions ziftomenib as a potential new SoC, presenting a promising therapeutic avenue for this hematologic malignancy.
Closing
With a new treatment paradigm in SCLC and the advancement of novel therapies entering new stages of disease, we are seeing a new wave of treatment options reach patients earlier in their disease course with the promise of improving outcomes, delaying progression, and extending life. Immunotherapy continues to remain a mainstay of treatment, showcasing why it has dominated the treatment options with its ability to improve on efficacy across a wide range of tumors, while novel modalities such as antibody-drug conjugates (ADCs) are poised to be the next big thing in cancer treatment.
Importantly, this year’s ASCO also highlighted the accelerating innovation in hematologic malignancies. The emergence of dual-targeting CAR-T constructs like KITE-363 in B-cell lymphoma and the promising data for ziftomenib in r/r NPM1-mutated AML demonstrate how heme-oncology is expanding the armamentarium with more targeted and potentially transformative options. These advances reinforce the cross-cutting progress across both solid and liquid tumors, underscoring the field’s commitment to delivering precision therapies that can meaningfully extend survival in historically hard-to-treat cancers.
About the Authors
Will Torres is a consultant at Lifescience Dynamics. He has over 6 years of life sciences consulting experience, working across a broad range of therapy areas, including oncology, rare disease, and infectious disease. Will has managed projects across a broad range of practice areas such as competitive intelligence, market research, and strategic advisory.
Maryam Youssef is a junior business analyst at Lifescience Dynamics. She works across multiple therapy areas, including vaccines, rare disease and oncology. Before joining Lifescience Dynamics, Maryam completed a Master’s from McGill University, specializing in mRNA therapeutics and viral vector biomanufacturing.
Kasia Koczula is an Engagement Manager at Lifescience Dynamics, bringing over eight years of consulting experience in the life sciences sector. She holds a PhD in hematological oncology and has worked across a broad range of therapy areas, including oncology, cardiovascular diseases, and rare diseases. Kasia specializes in competitive intelligence, market research, and strategic advisory services, supporting clients with evidence-based insights to drive informed decision-making.
Filed Under: Oncology
