The defining idea of 2025 was execution at scale—more patients pulled into earlier lines, more antibody–drug conjugates (ADCs) competing in crowded biology, and more “how it’s delivered” innovation (subcutaneous dosing, reduced chair time, and diagnostics that keep pace).
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The year’s storyline: Three Oncology Shifts That Repeatedly Emerged in 2025
Across tumor types, 2025 updates clustered around three recurring shifts.
Earlier-line ambition became the default.
Multiple programs pushed immunotherapy and targeted agents into perioperative or curative-intent settings—NSCLC, head and neck cancer, gastric/GEJ, bladder—shifting value propositions from incremental late-line benefit to event-free survival and recurrence risk reduction.
ADCs moved from “promising” to portfolio-defining.
From Nectin-4 and HER2 to B7-H3, CLDN18.2, CDH6, EGFR/MET and beyond, the file documented a steady flow of approvals, designations, and Phase 3 initiations—plus large-dollar partnering that underscored strategic urgency.
Convenience and throughput became competitive features, not footnotes.
Subcutaneous checkpoint inhibitors, ENHANZE-enabled delivery, reduced infusion reactions, and at-home administration preferences increasingly appeared alongside efficacy—implicitly reframing “best therapy” as “best therapy that systems can deliver.”
Multiple PD‑1/PD‑L1 approvals in gastric/GEJ, bladder, colorectal, and nasopharyngeal carcinoma made checkpoint blockade the default in many frontline and perioperative algorithms, marking “operationalization of immunotherapy” as a system-level phenomenon
Practice-Shaping Clinical Readouts in Oncology That Defined 2025
1) Extensive-stage SCLC: survival gains and new target classes (IMDELLTRA; IMforte)
Amgen’s DLL3-targeting bispecific T-cell engager IMDELLTRA reported an overall survival advantage in relapsed SCLC: in the Phase 3 DeLLphi-304 trial (n=509), median overall survival was 13.6 months versus 8.3 months, with a 40% reduction in risk of death and both OS and PFS endpoints met (ASCO; NEJM).
Roche’s Phase 3 IMforte trial added another survival-positive axis in ES-SCLC: Tecentriq (atezolizumab) + Zepzelca (lurbinectedin) improved survival versus Tecentriq alone, with a 46% risk reduction in PFS and 27% reduction in OS risk, and median overall survival improving from 10.6 to 13.2 months (ASCO; The Lancet).
PharmaMar subsequently cited IMforte in support of an EMA filing for lurbinectedin + atezolizumab.
2) EGFR-mutant NSCLC: regimen differentiation plus delivery innovation (MARIPOSA; SC formats)
Updated MARIPOSA data showed RYBREVANT (amivantamab) + lazertinib with an overall survival signal versus osimertinib: hazard ratio 0.75, with 56% alive at 3.5 years versus 44% on osimertinib; median OS was not yet reached for the combination.
In parallel, subcutaneous delivery became a meaningful operational lever. The file described CHMP positive opinion for subcutaneous amivantamab based on PALOMA-3, emphasizing shorter administration time and reduced infusion-related reactions compared with IV.
Merck’s Phase 3 3475A-D77 supported a subcutaneous Keytruda noninferiority package (comparable efficacy/pharmacokinetics versus IV), with an approximately 50% reduction in total treatment time; regulatory reviews were described as ongoing in the U.S. and EU in one section of the file, and later as broad EU coverage for subcutaneous pembrolizumab.
3) Perioperative immunotherapy: recurrence risk and event-driven endpoints (AEGEAN; KEYNOTE-689; CheckMate programs)
AstraZeneca’s Imfinzi (durvalumab) repeatedly appeared in perioperative and curative-intent contexts. In resectable NSCLC, the AEGEAN trial was cited as showing a 32% reduction in risk of recurrence or death with perioperative Imfinzi plus chemotherapy.
In head and neck cancer, the KEYNOTE-689 trial was described as a landmark for resectable locally advanced HNSCC, reporting a 27% to 34% reduction in event-free survival events and characterized as the first positive trial in more than twenty years in that setting (AACR 2025).
BMS also reported mature overall survival confirmation from CheckMate-816 for neoadjuvant Opdivo plus chemotherapy in resectable NSCLC, reinforcing early-stage positioning.
4) ADC competition: HER2, TROP2, Nectin-4, and the “pan-tumor” push (Enhertu; Datroway; CRB-701 and others)
In breast cancer, Enhertu expanded across HER2-low/ultralow disease in Europe, supported by DESTINY-Breast06 (median PFS 13.2 vs 8.1 months versus chemotherapy).
Daiichi Sankyo’s Datroway launched in Japan for HR-positive/HER2-negative breast cancer after prior chemotherapy; TROPION-Breast01 was cited with a 37% reduction in risk of progression or death versus chemotherapy, and interstitial lung disease reported in 6.5% of Japanese patients.
Nectin-4 remained a high-value battlefield, spanning approvals and designations: the file noted Corbus’ CRB-701 receiving FDA Fast Track in post–platinum/anti-PD(L)-1 HNSCC, plus additional Nectin-4 targeting development and cervical cancer Fast Track activity (ADRX-0706).
Separately, partnering activity reinforced how central ADC platform ownership became in 2025, including the AbbVie–Xilio collaboration around masked T-cell engagers and multiple ADC discovery/licensing deals.
5) Platinum-resistant ovarian cancer: OS signals re-enter the conversation (ROSELLA; KEYNOTE-B96; VITAL)
Corcept’s Phase 3 ROSELLA trial in platinum-resistant ovarian cancer met both PFS and OS endpoints: median PFS 6.5 vs 5.5 months, and median OS 16.0 vs 11.5 months, with regulatory submissions planned for the second half of 2025.
Merck’s KEYNOTE-B96 was described as meeting PFS and OS endpoints in platinum-resistant ovarian cancer, and framed as the first time an immune checkpoint inhibitor demonstrated an overall survival benefit in this indication, with greatest benefit in PD-L1–positive patients.
The file also highlighted FDA RMAT designation for gemogenovatucel-T in homologous recombination proficient ovarian cancer, citing VITAL trial OS benefit with 92% two-year OS versus 55% for placebo.
While IO, ADCs and subcutaneous delivery, cell therapy and radioligand therapy remained strategically important pillars in 2025, Pluvicto’s earlier-line expansion plus key pipeline assets and constraints (PSMA imaging access, isotope supply), stressing that radiotheranostics are moving from niche to strategic pillar status
Key Oncology Approvals, Guidelines, and Access Decisions in 2025
United States: Oncology 2025 FDA approvals, label expansions, and priority review
The file included multiple U.S. actions, notably: FDA approval of cabozantinib for progressive pancreatic and extra-pancreatic neuroendocrine tumors (CABINET: median PFS 13.8 vs 3.3 months versus placebo; Project Orbis noted), plus FDA expansion of Pluvicto into pre-chemotherapy mCRPC (PSMAfore: 59% reduction in radiographic PFS risk).
FDA approvals also included Opdivo + Yervoy in first-line unresectable/metastatic HCC (CheckMate-9DW: 38% alive at three years vs 24% in comparator; 21% reduction in death risk), and Opdivo + Yervoy for first-line MSI-H/dMMR metastatic colorectal cancer (CheckMate-8HW: 79% reduction in disease progression versus chemotherapy).
Merck’s WELIREG (belzutifan) received FDA approval in pheochromocytoma/paraganglioma (warnings for anemia and hypoxia), and AbbVie’s EMRELIS gained FDA approval for previously treated NSCLC with high c-Met protein overexpression (LUMINOSITY: 35% response rate, with patient selection via VENTANA MET RxDx).
Late in the year, FDA approved KEYTRUDA QLEX (subcutaneous pembrolizumab + berahyaluronidase) across most solid tumor indications, supported by Phase 3 D77 exposure and ORR comparability, with 1–2 minute administration by HCP.
Europe and the UK: EC Oncology approvals, CHMP opinions, and NICE/MHRA actions
In the EU, the European Commission approved multiple high-impact moves: perioperative Opdivo-based regimen in high-risk resectable NSCLC (CheckMate-77T: 42% improvement in event-free survival), approval of Enhertu in HER2-low/ultralow breast cancer, and EU approvals/recommendations involving Imfinzi across settings including limited-stage SCLC and perioperative bladder cancer positioning via NIAGARA metrics (risk reductions in recurrence and death).
CHMP activity frequently telegraphed near-term market changes: positive opinions for Phesgo (supporting at-home use; 85% patient preference for SC; potential cost reductions up to 80%), for subcutaneous Opdivo across tumors, and for multiple tumor-type expansions referenced in the file.
2025 regulatory actions (e.g., perioperative durvalumab approvals in high-risk resectable NSCLC and muscle‑invasive bladder cancer where granted) converted AEGEAN/NIAGARA-type signals into practice, closing the loop between trials and guidelines
In the UK, MHRA approval was cited for subcutaneous nivolumab, reducing infusion time from 60 minutes to 5 minutes for more than 3,600 patients, and NICE recommended enfortumab vedotin + pembrolizumab as first-line therapy for advanced bladder cancer through the NHS (median OS 33.8 vs 15.9 months versus chemotherapy)
Oncology Regulatory Activity Across Canada and Asia-Pacific in 2025: Health Canada, Japan, China, Singapore, Taiwan
Health Canada approvals and actions included KEYTRUDA perioperative NSCLC, conditional NOC for Tagrisso in Stage III EGFR-mutant NSCLC (LAURA: median PFS 39.1 vs 5.6 months), and approvals spanning cervical cancer chemoradiotherapy combinations and other indications described in the file.
Japan updates included approvals and launches such as Datroway and approval of TIVDAK for cervical cancer (innovaTV 301: 30% reduction in death risk; median OS 11.5 vs 9.5 months).
China’s NMPA and related actions included approval of trastuzumab rezetecan for HER2-mutant NSCLC (HORIZON-Lung: ORR 74.5%, median PFS 11.5 months) and multiple Breakthrough Therapy Designations and submissions described across gastric/GEJ, liver cancer, melanoma, and more.
Singapore and Taiwan decisions included approvals of IO regimens (e.g., toripalimab in nasopharyngeal carcinoma in Singapore; Opdivo + Yervoy in HCC in Taiwan), reflecting the file’s emphasis on multi-region regulatory momentum.
Further, ADC approvals or pivotal readouts in breast and lung (e.g., new TROP2 or HER3 ADCs entering late-stage development), emphasizing crowding of HER2, TROP2, Nectin‑4, and other targets
Safety and Delivery Activity in Oncology in 2025: Keeping Patients on Therapy
Several updates framed safety and logistics as core determinants of adoption.
Shorter administration and fewer infusion reactions
Shorter administration and fewer infusion reactions were explicit advantages for subcutaneous and ENHANZE-enabled products, including subcutaneous amivantamab (reduced infusion-related reactions) and subcutaneous Keytruda (nearly 50% reduced total treatment time in D77; 1–2 minute administration described for QLEX).
Toxicity signals remained differentiators inside crowded ADC classes
Datroway’s Japanese launch included common adverse events (nausea, stomatitis, fatigue) and interstitial lung disease in 6.5% of Japanese patients; other ADC programs were positioned around improving specificity and reducing systemic toxicity.
Label warnings and selection tools mattered for execution
WELIREG carried warnings for anemia and hypoxia; EMRELIS paired a defined response rate with a companion diagnostic (VENTANA MET RxDx), linking safety/efficacy to test-and-treat readiness.
Finally, supportive-care adjacent development—such as ZetaMet for lytic bone lesions and cachexia trials in colorectal cancer—reflected ongoing attention to keeping patients eligible for systemic therapy and maintaining dose intensity.
2025 intensified oncology pricing and HTA pressures, as NICE and other agencies increasingly scrutinized expensive launches such as enfortumab vedotin plus pembrolizumab for bladder cancer and advanced cell/radioligand therapies against fixed budgets, so real‑world deployability depends not just on clinical benefit and approvals but also on affordability levers like confidential discounts, outcomes‑based contracts, and managed access schemes
Diagnostics and Patient Matching in Oncology in 2025: Faster Selection and Better Stratification
Diagnostics and data infrastructure advanced on multiple fronts.
Imaging as a gatekeeper for therapy continued to expand
Curium’s PYLCLARI was approved in Switzerland for PSMA-PET imaging (now authorized in 12 European countries), and Clarity launched Phase 3 AMPLIFY for 64Cu-SAR-bisPSMA PET imaging in biochemically recurrent prostate cancer across the U.S. and Australia.
Companion diagnostics widened therapeutic addressable markets.
The VENTANA HER2 (4B5) RxDx assay gained CE-IVDR expansions enabling HER2-ultralow selection for Enhertu and HER2-positive BTC selection for zanidatamab eligibility.
Testing standards moved into routine care pathways.
Caris expanded MET immunohistochemistry testing to all non-squamous NSCLC cases, describing MET overexpression in ~25% of patients, aligning diagnostics with emerging MET-directed strategies.
Beyond testing, the file highlighted enabling technologies—Roche’s “sequencing by expansion” to reduce sample-to-genome time from days to hours, and AI-driven stratification tools such as Owkin K—underscoring how speed in patient selection is increasingly part of competitive advantage.
Oncology 2025 Catalyst calendar (only timelines explicitly stated)
First Half of 2025
- Theriva: topline efficacy readout anticipated Q2 2025 for VCN-01 in pancreatic ductal adenocarcinoma (to inform Phase 3 design).
- IDEAYA: Phase 3 trial planned first half of 2025 for darovasertib in uveal melanoma (520 patients; eye preservation focus).
- Cardiff Oncology: final data expected first half of 2025 for onvansertib plus standard-of-care in first-line RAS-mutant mCRC.
Mid-2025
- Trials described as set to begin mid-2025, including Summit/Pfizer collaboration plans and ALX2004 Phase 1 scheduled to begin mid-2025.
Q3–Q4 2025
- FDA decision expected Q3 2025 for Boehringer Ingelheim’s zongertinib in HER2-mutant NSCLC (Priority Review).
- IND submission planned Q4 2025 for Atossa’s (Z)-Endoxifen program; reimbursement price expected Q4 2025 for IBTROZI in Japan; IND planned Q4 2025 for FG001 in high-grade glioma surgery imaging.
- Progression-free and overall survival data expected Q4 2025 for tovecimig in biliary tract cancer.
- Zetagen: topline results expected Q4 2025 for ZetaMet in metastatic breast cancer bone lesions.
2026 and beyond
- Phase 1b MELODY-1 (MB097 + pembrolizumab) results expected 1H 2026.
- Lantern: pediatric CNS trial start targeted Q1 2026 (LP-184/STAR-001).
- Candel: potential BLA submission targeted end of 2026 for CAN-2409 in localized prostate cancer.
- Novocure: FDA decision expected second half of 2026 for TTFields in pancreatic cancer (PANOVA-3 PMA).
- ITM: PDUFA date 28 Aug 2026 for 177Lu edotreotide (ITM-11) in GEP-NETs.
Key Oncology Takeaways From 2025
Oncology’s 2025 pattern was clear: more pivotal readouts and approvals in lung, bladder, GI, and women’s cancers; a sustained wave of ADC maturation; and a visible pivot toward delivery efficiency (subcutaneous IO, reduced chair time) and diagnostics infrastructure (CDx expansion, PSMA-PET scale, faster sequencing). For investors and C-suite teams, throughline is that competitive advantage increasingly sits at the intersection of clinical effect, regulatory reach, and real-world deployability.
Expanding diagnostic infrastructure suggests that 2026–2027 competitiveness will hinge as much on operational readiness and testing access as on trial readouts, with scalable companion diagnostics and biomarker-ready workflows becoming prerequisites for capturing value from radioligands, ADCs and perioperative IO launches
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