cisplatin / Generic mfg. - LARVOL DELTA

IMvigor011: a study of adjuvant atezolizumab in patients with high-risk MIBC who are ctDNA+ post-surgery. (PubMed, Future Oncol) - P3 | "The standard-of-care for muscle-invasive bladder cancer is radical surgery with neoadjuvant cisplatin-based chemotherapy. IMvigor011 (NCT04660344) is a global, double-blind, randomized phase III study assessing the efficacy of atezolizumab (anti-PD-L1) versus placebo in patients with high-risk muscle-invasive bladder cancer who are ctDNA positive post-cystectomy. The primary end point is disease-free survival in participants who are ctDNA positive within 20 weeks of cystectomy."

Circulating tumor DNA • Journal • Post-surgery • Review • Surgery • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Oncology • Solid Tumor • Urothelial Cancer

Safety and efficacy of neoadjuvant immunotherapy with durvalumab (MEDI 4736) in combination with neoadjuvant chemotherapy (gemcitabine/cisplatin or carboplatin) in patients with operable high-risk upper tract urothelial carcinoma. (ASCO-GU 2025) - P2 | "Combination of durvalumab with platin-based chemotherapy, especially cisplatin, showed promising activity in UTUC, with the occurrence of complete responses and a high rate of non-infiltrative residual tumor. Safety profile was secure without increasing surgical risk. A randomized Phase 3 controlled study comparing neoadjuvant chemotherapy with chemotherapy combined with immunotherapy in patients with high-risk localized UTUC (iNDUCT-3) will open soon to validate these encouraging results."

Clinical • Combination therapy • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. (ASCO 2025) - P3 | "Pts were randomized 1:1 to receive either neoadjuvant D (1500 mg IV Q3W) and NAC (cisplatin + gemcitabine IV Q3W) for 4 cycles followed by RC, then adjuvant D monotherapy (1500 mg IV Q4W) for 8 cycles (D arm), or NAC followed by RC alone (comparator [C] arm). In this exploratory analysis, ctDNA+ status at pre-RC was associated with non-pCR. Higher ctDNA clearance from baseline to pre-RC in the D arm indicated the additional benefit of D plus NAC vs NAC alone. Perioperative D provided an EFS benefit to both pts with ctDNA+ and ctDNA− status at baseline; a similar trend was observed with DFS based on ctDNA status post-RC."

Circulating tumor DNA • Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). (ASCO 2025) - P3 | " Pts were randomized 1:1 to receive EV (1.25 mg/kg; Days 1 and 8; IV) + P (200 mg; Day 1; IV) or chemo (gemcitabine + cisplatin/carboplatin); all Q3W. In the EV+P arm, the proportion of pts achieving cCR was twice that in the chemo arm. Consistent with the ITT data, EV+P reduced the risk of progression or death vs chemo in pts achieving cCR, with appropriate dose modifications. These data reinforce EV+P as the SOC for 1L tx of pts with la/mUC."

Metastases • P3 data • Oncology • Solid Tumor • Urothelial Cancer

Neoadjuvant and adjuvant pembrolizumab plus standard of care (SOC) in resectable locally advanced head and neck squamous cell carcinoma (LA HNSCC): Exploratory efficacy analyses of the phase 3 KEYNOTE-689 study. (ASCO 2025) - P3 | " Adults with SCC of the larynx/hypopharynx/oral cavity (stage III/IVA) or oropharynx (stage III/IVA p16− or stage III T4 N0-2 p16+) were randomized 1:1 to SOC (consisting of surgery + postoperative radiotherapy [PORT] ± concurrent cisplatin 100 mg/m2 Q3W) with or without 2 cycles of neoadjuvant pembrolizumab, 3 cycles of pembrolizumab concurrent with PORT ± cisplatin and 12 cycles of adjuvant pembrolizumab (200 mg IV Q3W). Among all pts with resectable LA HNSCC in KEYNOTE-689, DMFS results and incidence of second cancers favored the addition of neoadjuvant/adjuvant pembrolizumab to SOC surgery and (chemo)radiotherapy, consistent with the primary EFS results of the study. Locoregional control was similar between arms. No new safety signals for pembrolizumab were observed."

Clinical • Metastases • P3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study. (PubMed, Lancet Oncol) - P3 | "Enfortumab vedotin plus pembrolizumab significantly improved survival outcomes versus platinum-based chemotherapy without detriment to GHS/QOL, pain, or functioning. Patients with moderate to severe baseline pain had clinically meaningful improvements in worst pain and GHS/QOL with enfortumab vedotin plus pembrolizumab. These data provide further evidence to support the use of enfortumab vedotin plus pembrolizumab as a preferred treatment option for patients with previously untreated locally advanced or metastatic urothelial cancer."

Clinical • IO biomarker • Journal • P3 data • Genito-urinary Cancer • Oncology • Pain • Solid Tumor • Urothelial Cancer • PD-L1

Sasanlimab as bladder-sparing maintenance treatment after neoadjuvant chemotherapy in patients with muscle invasive bladder cancer (MIBC): The phase 2, SASAN-SPARING trial. (ASCO 2025) - P2 | "Patients are ≥ 18 years, ECOG 0-1 and treatment-naïve for MIBC candidates to receive neoadjuvant cisplatin/gemcitabine followed by RC. Study of biomarkers will provide a useful tool to corroborate achievement of a clinical complete response, contributing to personalized treatments. The study is approved and started with recruitment of patients in December 2024."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: primary results of a multicentre, single-arm, phase 2 study. (PubMed, Lancet Oncol) - P2 | "Zanidatamab plus chemotherapy as first-line treatment of HER2-positive advanced gastro-oesophageal adenocarcinoma demonstrated clinically meaningful and durable antitumour activity, with a manageable safety profile."

Journal • P2 data • Acute Kidney Injury • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Nephrology • Oncology • Renal Disease • Solid Tumor • HER-2

Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. (PubMed, N Engl J Med) - P3 | "The addition of neoadjuvant and adjuvant pembrolizumab to standard care significantly improved event-free survival among participants with locally advanced HNSCC. Neoadjuvant pembrolizumab did not affect the likelihood of surgical completion. No new safety signals were identified. (Funded by Merck Sharp and Dohme, a subsidiary of Merck [Rahway, NJ]; KEYNOTE-689 ClinicalTrials.gov number, NCT03765918.)."

Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Molecular Residual Disease (MRD) Analysis from NeoADAURA: Neoadjuvant Osimertinib ± Chemotherapy in Resectable EGFRm NSCLC (IASLC-WCLC 2025) - P3 | "Methods : Adult patients with resectable EGFRm (Ex19del/L858R) stage II-IIIB NSCLC and WHO PS ≤1 were randomised 1:1:1 to neoadjuvant osimertinib 80 mg QD (≥9 weeks) + chemotherapy (cisplatin/carboplatin+pemetrexed; 3 cycles, Q3W), osimertinib monotherapy 80 mg QD (≥9 weeks), or placebo QD (≥9 weeks) + chemotherapy (3 cycles, Q3W), followed by surgery. The tumour-informed, ctDNA-based MRD assay had a greater tumour detection rate vs single EGFR gene mutation testing. Baseline MRD status was prognostic for clinical outcomes. Osimertinib-containing regimens improved pre-surgical MRD clearance vs placebo+CT; pre-surgical MRD- and clearance were associated with MPR."

Clinical • Residual disease • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

COMPEL: Osimertinib + Platinum-Based Chemotherapy in Patients With EGFRm Advanced NSCLC and Progression on 1L Osimertinib (IASLC-WCLC 2025) - P3 | "Methods : Adult patients progressing on 1L osimertinib without CNS progression were randomised 1:1 to receive either osimertinib 80 mg once daily (QD) or placebo QD in combination with platinum-pemetrexed chemotherapy (cisplatin 75 mg/m 2 or carboplatin AUC5 + pemetrexed 500 mg/m 2 for 4 cycles every 3 weeks [Q3W]), followed by osimertinib 80 mg QD or placebo QD in combination with maintenance pemetrexed (500 mg/m 2 Q3W) until disease progression or another discontinuation criterion was met. The combination of osimertinib + chemotherapy had a manageable safety and tolerability profile, consistent with the individual safety profiles for each drug. Together these results support osimertinib as a backbone treatment for EGFRm advanced NSCLC, which may help inform treatment decisions based on individual patient characteristics."

Clinical • Metastases • Anemia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor

Comprehensive Patient Reported Outcomes (PROs) from NRG LU005: A Randomized Trial Of Chemoradiation (CRT) +/- Atezolizumab In Limited-Stage Small Cell Lung Cancer (LS-SCLC) (ASTRO 2025) - "Materials/ Patients (N=544) were randomized to standard CRT (platinum/etoposide q3 weeks x 4 cycles + thoracic RT [45 Gy BID or 66 Gy daily] starting @ cycle 2 of chemo) +/- atezolizumab q3 weeks x 1 year starting @ cycle 2 of chemo. Stratification factors (SFs) included RT schedule (BID vs daily), chemo type (cisplatin vs carboplatin), sex, and ECOG performance status (PS)... As hypothesized, the addition of atezolizumab to CRT was associated with clinically meaningful improvements in longer term QOL (FACT-TOI), as well similar QAS with no negative impact on fatigue. To our knowledge, this is the first large trial to show that BID (vs daily) RT was associated with not only improved median OS, but also consistently more favorable PRO trajectory with significantly lower CMD in FACT-TOI. Conducted in the context of modern RT (IMRT ~90%), this analysis helps to address lingering concerns about BID RT's impact on QOL and provides further support for BID RT in LS-SCLC..."

Clinical • Late-breaking abstract • Patient reported outcomes • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ZG005 in combination with etoposide and cisplatin for the first-line treatment of advanced neuroendocrine carcinoma (ESMO 2025) - P1/2 | "Background Advanced neuroendocrine carcinoma (NEC) has limited therapeutic options, with etoposide/cisplatin (EP) or etoposide/carboplatin (EC) remaining as the first-line standard. Serious adverse events occurred in 20.7% of pts in the ZG005+EP arms, with two cases (immune-mediated enterocolitis and subclinical myocarditis) deemed treatment-related. Conclusions The combination of ZG005 with standard EP based chemotherapy showed a favorable safety profile and encouraging anti-tumor activities in pts with NEC."

Clinical • Combination therapy • Metastases • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • TIGIT

DISCUS: A phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer (ESMO 2025) - P2 | "Methods Pts with previously untreated aUC were randomized 1:1 to receive 3 (3C arm) or 6 (6C arm) cycles of gemcitabine/cisplatin or gemcitabine/carboplatin, followed by maintenance avelumab. Grade 3–4 TRAEs occurred in 11.9% (3C) vs 15.7% (6C). Conclusions Three cycles of platinum-based chemotherapy followed by avelumab provides better QoL compared with six cycles, and similar OS without compromising efficacy."

Clinical • Late-breaking abstract • Metastases • P2 data • Genito-urinary Cancer • Oncology • Urothelial Cancer

Final Results from a First-in-Human Phase 1 Study of the Dual Isocitrate Dehydrogenase (IDH) 1/2 Inhibitor, LY3410738, in Advanced Solid Tumors Harboring IDH1 or IDH2 Mutations. (PubMed, Clin Cancer Res) - P1 | "LY3410738 demonstrated largely cytostatic antitumor activity in IDH1- or IDH2-mutated cholangiocarcinoma and IDH1-mutated gliomas. LY3410738 plus cisplatin-gemcitabine exhibited favorable antitumor activity in patients with treatment-naïve IDH-mutated cholangiocarcinoma, warranting further exploration as a treatment strategy."

First-in-human • Journal • P1 data • Biliary Cancer • Brain Cancer • Cholangiocarcinoma • Glioma • Oncology • Solid Tumor • IDH1 • IDH2

RTOG 1016 long-term update and smoking analysis (ESMO 2025) - P3 | "Background RTOG 1016 was a noninferiority phase 3 trial that compared overall survival (OS) for patients with HPV-positive oropharyngeal cancer (OPC) randomized to cisplatin (n=406) or cetuximab (n=399) with intensity-modulated radiotherapy (IMRT). Hearing-related toxicities were more frequent in the cisplatin arm. Current smoking at diagnosis was associated with worse survival."

Head and Neck Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor

Survival with Osimertinib plus Chemotherapy in EGFR-Mutated Advanced NSCLC. (PubMed, N Engl J Med) - P3 | "Among patients with EGFR-mutated advanced NSCLC, first-line treatment with osimertinib plus platinum-pemetrexed led to significantly longer overall survival than osimertinib monotherapy and was associated with an increased risk of reversible adverse events of grade 3 or higher. (Funded by AstraZeneca; FLAURA2 ClinicalTrials.gov number, NCT04035486.)."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Concurrent chemoradiotherapy with/without adjuvant capecitabine in locoregionally advanced nasopharyngeal carcinoma: A randomized controlled phase III trial (ESMO 2025) - P3 | "All patients were randomly assigned in a 1:1 ratio to receive CCRT (3-weekly cisplatin at 100 mg/m 2 for 2-3 cycles) followed by AC (1000 mg/m 2 bi-daily for 14 days every 21-day cycle for 8 cycles), or CCRT alone. The most common ≥grade 1 toxicities relating capecitabine included anemia (60.1%), leukopenia (47.6%), and hand-foot syndrome (44.1%); and the most common grade 3-4 toxicities relating capecitabine included neutropenia (3.5%), hand-foot syndrome (2.8%), and leukopenia (1.4%). Conclusions Adding adjuvant capecitabine after CCRT conferred superior survivals than CCRT alone in LANPC patients, with mild toxicities."

Clinical • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Clinical Characteristics and Surgical Outcomes of Patients Receiving Perioperative Pembrolizumab in KEYNOTE-671. (PubMed, Ann Thorac Surg) - P3 | "Neoadjuvant pembrolizumab did not adversely affect surgical outcomes, was associated with numerically higher R0 resections, and improved EFS versus neoadjuvant chemotherapy in surgically relevant subgroups in early-stage NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

TOURMALINE study of durvalumab (D) in combination with gemcitabine (G)-based chemotherapy in advanced biliary tract cancer (aBTC): early safety and efficacy results in participants (pts) from Asia (ESMO Asia 2025) - P3 | "We report early safety and efficacy data within a subgroup of pts from Asia. Pts receive D 1500 mg (first infusion: 60 min; subsequent infusions: 30 min) with an investigator-selected G-based chemotherapy (D + G alone or in combination with oxaliplatin [O], carboplatin [C], cisplatin [cis], tegafur-gimeracil-oteracil [S-1], cis + S-1, or cis + nab-paclitaxel [P]). In pts from Asia, the safety profiles of all study tx were manageable. Safety results for pts from Asia were comparable to the global TOURMALINE population and TOPAZ-1 study. Interim ORR is promising."

Clinical • Combination therapy • Metastases • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. (ASCO-GI 2026) - P3 | "Background: HERIZON-GEA-01 (NCT05152147) is a global, open-label, phase 3 trial of zanidatamab (dual HER2-targeted bispecific antibody) + CT ± tislelizumab (anti–PD-1) vs trastuzumab (tras) + CT in 1L HER2+ mGEA. Eligible patients (pts) with previously untreated HER2+ mGEA, regardless of PD-L1 status, were randomized (1:1:1) to zanidatamab (1800 mg [12 mo) vs tras + CT. Zanidatamab + tislelizumab + CT also provided a statistically significant and clinically meaningful OS benefit (mOS >26 mo). The trial is ongoing with additional OS analyses planned for zanidatamab + CT."

Clinical • Late-breaking abstract • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

First-line tiragolumab plus atezolizumab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic oesophageal cancer (MORPHEUS-EC): a randomised, open-label, phase 1b/2 trial. (PubMed, Lancet Oncol) - P1/2, P3 | "These results support the additional benefit of tiragolumab combined with atezolizumab and chemotherapy for patients with treatment-naive, locally advanced unresectable or metastatic oesophageal cancer. Further validation of tiragolumab plus atezolizumab and chemotherapy has been performed in the phase 3 SKYSCRAPER-08 trial (NCT04540211)."

Clinical • Journal • P1/2 data • Esophageal Cancer • Oncology • Solid Tumor • TIGIT

A phase II study of pembrolizumab plus chemotherapy with short-course radiotherapy as induction treatment for unresectable locally advanced esophageal squamous cell carcinoma: PALADIN trial. (ASCO-GI 2026) - "Patients receive pembrolizumab 200 mg IV on day 1, cisplatin 80 mg/m² IV on day 1, and 5-fluorouracil 800 mg/m²/day by continuous infusion on days 1–5 every 3 weeks for 4 cycles, with SCRT of 25 Gy in 5 fractions administered on days 8–12 of cycle 1. The planned sample size is 35 patients, based on a threshold 2-year OS rate of 30% and an expected rate of 50%, with a one-sided α of 0.10 and 80% power. Patient enrollment began in July 2025."

Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology

Savolitinib plus osimertinib versus chemotherapy for advanced, EGFR mutation-positive, MET-amplified non-small-cell lung cancer in China (SACHI): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial. (PubMed, Lancet) - P3 | "The savolitinib-osimertinib combination improved PFS versus chemotherapy in patients with EGFR mutation-positive, MET-amplified NSCLC that had progressed on EGFR TKI therapy, while maintaining a favourable tolerability profile. This regimen offers a potential oral treatment option for this biomarker-selected population."

Journal • P3 data • P3 data: top line • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. (ASCO-GU 2026) - P3 | "Clinical Trial Registry Number: NCT04700124. The full, final text of this abstract will be available on Feb 27 at 10:00 AM EST."

Clinical • Late-breaking abstract • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor