pemetrexed / Generic mfg. - LARVOL DELTA

REVIVE: Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC. (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: AstraZeneca

Biomarker • New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Trial in progress: A phase 3, multi-regional, open-label, randomized study of tirabrutinib vs rituximab and temozolomide in participants with Relapsed/Refractory primary central nervous system lymphoma (ASH 2025) - P2, P3 | "No approved therapies for relapsedor refractory (r/r) disease exist in the US or EU, and NCCN guideline-recommended treatment optionsbased on small studies can be divided into high-dose chemotherapy (HDC) with or without autologousstem cell transplantation (ASCT), whole brain radiation therapy (WBRT), or treatment with better-tolerated regimens such as temozolomide (TMZ) or lenalidomide with or without rituximab (RTX), RTX,pomalidomide, ibrutinib, or pemetrexed...Tumor response assessment will be performed at screening, C2D1, C3D1, thenevery 2 cycles through C25D1, and every 4 cycles thereafter according to IPCG criteria. ClinicalTrials.govregistration number: NCT07104032."

Clinical • P3 data • CNS Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Pruritus

Tisotumab vedotin vs investigator's choice of chemotherapy as second- or third-line (2L/3L) treatment for Chinese patients (pts) with recurrent or metastatic cervical cancer (r/mCC) in innovaTV 301 (ESMO Asia 2025) - P3 | "This report presents the first analysis of efficacy and safety of TV in Chinese pts with r/mCC, based on data from both global and China extension portions within innovaTV 301. Eligible pts had r/mCC with disease progression following standard chemotherapy doublet ± bevacizumab ± anti-PD-(L)1 therapy, measurable disease per RECIST v1.1, and an ECOG performance status of 0-1. Pts were randomised 1:1 to receive TV monotherapy or investigator's choice of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed... TV as 2L/3L treatment demonstrated clinically meaningful improvements in OS, PFS, and ORR vs chemotherapy, with a manageable safety profile, for Chinese pts with r/mCC."

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Crizotinib plus chemotherapy versus crizotinib alone in advanced non-small cell lung cancer with ALK rearrangement (ESMO Asia 2025) - "Background: Lorlatinib, a 3rd-gen ALK inhibitor (ALKi), & 2nd-gen ALK inhibitors are recommended for the treatment of advanced ALK-rearranged NSCLC...Participants were randomized 1:1 to receive Crizotinib 250 mg BD or Crizotinib 250 mg BD + Pemetrexed 500mg/m2 + Carboplatin AUC 5 q3w; followed by Crizotinib + Pemetrexed... The combination of crizotinib + chemotherapy did not improve the DCR and PFS in patients with ALK re-arranged NSCLC."

Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • ALK

A 66-Year-Old Woman with EGFR-Mutant Lung Adenocarcinoma and Brain Metastases Achieving 96-Month Overall Survival with serially deploying three distinct third-generation EGFR-TKIs (ESMO Asia 2025) - "First-line icotinib plus paclitaxel/nedaplatin was given and achieved PR and 36-month PFS...Osimertinib 80mg qd combined with pemetrexed chemotherapy for 5 cycles, followed by osimertinib monotherapy, yielded 25-month PFS until isolated CNS progression. Despite concomitant whole-brain radiotherapy and bevacizumab with Osimertinib, intracranial lesions advanced...This exceptional survival in advanced EGFR+ NSCLC was achieved through initial chemo-TKI therapy, sequential third-generation TKIs (osi→almo→furmo) for CNS control, and furmonertinib dose escalation for late CNS progression. The persistent TP53 co-mutation suggests a resistance mechanism, while PD-L1 negativity excluded immunotherapy, demonstrating the efficacy of optimized TKI sequencing alone."

Clinical • IO biomarker • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TP53

Platinum-Pemetrexed Plus Osimertinib Beyond Progression Achieves Complete Metabolic Response in EGFR Exon 19-Deleted Metastatic NSCLC (ESMO Asia 2025) - "He received cisplatin 75mg/m2 and pemetrexed 500mg/m2 3 weekly for 4 cycles with continued osimertinib. Novel targeted agents and ADCs show promise. Ongoing trials, COMPEL and FLAME are assessing chemotherapy plus osimertinib beyond progression or in early ctDNA persistence."

Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • EGFR • KRAS • PIK3CA

A patient with metastatic upper tract urothelial carcinoma with EGFR exon 20 insertion and MTAP loss responding to amivantamab and pemetrexed-based chemotherapy (ESMO Asia 2025) - P2 | "Gemcitabine and carboplatin were started but lung metastasis worsened. He was switched to pembrolizumab without significant response. He was then given sacituzumab govitecan, with initial improvement but progressed later. He later had enfortumab vedotin and rechallenged carboplatin with nab-paclitaxel, and had further enlargement of lung metastasis...Our case offers insights into a patient with refractory urothelial carcinoma with EGFR exon 20 insertion and MTAP loss, having early and durable response to amivantimab and pemetrexed-carboplatin despite the failure of multiple prior therapies. This supports further investigation of broad molecular profiling and biomarker-guided trials in urothelial carcinoma to understand tissue-specific effects of genetic alterations."

Clinical • EGFR exon 20 • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CDKN2A • CDKN2B • EGFR • FGFR • HER-2 • MTAP • PD-L1 • PIK3CA • TP53

Lazertinib with or without chemotherapy in MRD positive, previously untreated EGFR-mutant, advanced NSCLC (CHAMELEON study) (ESMO Asia 2025) - P2 | "Assuming an MRD positivity rate of 70%, MRD-positive patients will be randomized to receive either escalated regimen (lazertinib plus platinum-based chemotherapy of pemetrexed 500mg/m2 plus carboplatin AUC5 (arm A, n=43) or continue lazertinib monotherapy (Arm B, n=43) while MRD negative patients will continue to receive lazertinib monotherapy (Arm C, n=37). Trial activation occurred on August 1, 2024. Results from this trial will provide evidence to the ongoing debate on the extent of benefit of chemotherapy to EGFR TKI monotherapy as well as define patient subgroups that will benefit most."

Metastases • Minimal residual disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

An Indian real world experience with pembrolizumab and chemotherapy in the first-line treatment of metastatic non-small cell lung cancer without actionable genomic alterations (ESMO Asia 2025) - "29 patients (58%) received pemetrexed + platinum chemotherapy while remaining (42%) received taxane based regimen. This is one of the first studies evaluating IO with chemotherapy in Indian setting. The study demonstrated a mPFS of 12 months & mOS of 28 months, exceeding those of landmark trials like KEYNOTE-189 & KEYNOTE-407. Our real-world experience with pembrolizumab & chemotherapy demonstrates encouraging survival outcomes & manageable toxicity, supporting its use as a first-line treatment for mNSCLC patients without AGAs in India."

Clinical • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

A new paradigm of using combination of osimertinib with chemotherapy for first-line treatment in EGFR mutated metastatic non-small cell lung cancer: A real-world Indian experience (ESMO Asia 2025) - "Real world data from India is limited. This is a retrospective, single-centre study, conducted from August 2021 to July 2025, which included patients with newly diagnosed EGFR-mutated (exon19 deletion or exon21 L858R) mNSCLC who received osimertinib combined with chemotherapy (pemetrexed plus carboplatin) for 4 cycles followed by maintenance osimertinib, with or without pemetrexed. Osimertinib combined with chemotherapy has demonstrated a longer PFS compared to historical data in our patient cohort. While it is associated with higher toxicity, these are generally clinically manageable. With the recently reported OS benefit from the FLAURA2 trial, this regimen is poised to become a standard of care for EGFR-mutated NSCLC, particularly in patients with a high disease burden, brain metastases, or EGFR-L858R mutations."

Clinical • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KEAP1 • PIK3CA • RB1 • TP53

Genomic landscape of advanced non-small cell lung cancer (aNSCLC) using circulating tumor DNA (ctDNA) next generation sequencing (NGS): A single-center analysis in Taiwan (TW) (ESMO Asia 2025) - "2021, pt was initiated on Crizotinib therapy, and achieved partial response (PR)... In this single-center study of aNSCLC pts in TW, ctDNA NGS identified genomic alts in more than three-quarters of cases with a swift mTAT, supporting its use to guide treatment decisions."

Biomarker • Circulating tumor DNA • Clinical • Metastases • Next-generation sequencing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS • PIK3CA • ROS1 • TP53

Gefitinib plus pemetrexed-platinum chemotherapy versus gefitinib monotherapy in untreated EGFR-mutant advanced NSCLC (ESMO Asia 2025) - "In patients with EGFR-mutant NSCLC, using GPP over gefitinib monotherapy showed significantly improved PFS. However, it is associated with a higher incidence of adverse events. Therefore, individualized treatment decisions balancing efficacy and safety are of paramount importance to optimize the clinical outcomes."

Metastases • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and safety of aumolertinib and intrathecal pemetrexed for TKI-failed leptomeningeal metastases from EGFR+ NSCLC: A single-arm, phase II clinical trial (ESMO Asia 2025) - P2 | "This study further showed that aumolertinib and IP is an effective and safe treatment method for the EGFR-TKI-failed NSCLC-LM, and should be recommended for these patients in clinical practice and guidelines."

Clinical • P2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Cadonilimab plus chemotherapy demonstrates clinically meaningful activity in treatment-refractory STK11-mutant advanced NSCLC: results from an open-label, single-arm phase II study (ESMO Asia 2025) - P2 | "Cadonilimab (AK104), a bispecific antibody targeting PD-1 and CTLA-4, enhances antitumor immunity through dual checkpoint inhibition. This phase II study evaluated first-line cadonilimab plus chemotherapy in advanced/metastatic STK11-mutant NSCLC. Eligible patients with stage IV STK11-mutant NSCLC received cadonilimab (10 mg/kg, D1) plus pemetrexed (500 mg/m2) and carboplatin (AUC=5) for 4 cycles, followed by Cadonilimab+pemetrexed maintenance for non-squamous histology; or Cadonilimab (10 mg/kg, D1) plus nab-paclitaxel (100 mg/m2) and carboplatin (AUC=5) for 4 cycles, followed by Cadonilimab+nab-paclitaxel maintenance for squamous histology... First-line cadonilimab plus chemotherapy demonstrated encouraging antitumor activity and manageable safety in advanced STK11-mutant NSCLC, with PFS nearly doubling historical expectations for this treatment-resistant subgroup. Updated survival data with longer follow-up will be presented at the Congress."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • STK11

Analysis of MET amplification (METamp) with FISH and NGS method in SACHI trial (ESMO Asia 2025) - P3 | "Background: In the Phase 3 SACHI trial (NCT05015608), savolitinib (savo) combined with osimertinib (osi) significantly improved progression-free survival (PFS) versus chemotherapy (pemetrexed plus carboplatin or cisplatin) for MET-amplified NSCLC patients (pts) who had progressed following EGFR-TKI treatment. FISH was more sensitive than NGS for detecting METamp, and the positive concordance depended on FISH-assessed MET GCN. In pts positive by both methods, savolitinib plus osimertinib significantly improved outcomes."

Next-generation sequencing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KIT • MET

Efbemalenograstim alfa as primary prophylaxis for concurrent chemo-radiotherapy induced neutropenia: Guard-01 results (ESMO Asia 2025) - P4 | "Subgroup analysis by regimen showed consistent benefit, with significant difference in paclitaxel- or pemetrexed- based subgroups (21.74% vs. 70.83%, p=0.0007). Efbemalenograstim alfa provides effective prophylaxis against grade 3/4 neutropenia in patients undergoing CCRT with a favorable safety profile."

Chemotherapy-Induced Neutropenia • Oncology

Clinical validation of a dual tissue and plasma companion diagnostic (CDx) kit for identification of NSCLC patients harboring EGFR exon 20 insertion for amivantamab therapy (ESMO Asia 2025) - P3 | "AmoyDx Essential NGS Kit (LC10) was validated as a dual tissue and plasma CDx for selection of EGFR Ex20ins NSCLC patients for PAPILLON (NCT04538664, ACP arm compared to CP arm; A- amivantamab; CP-chemotherapy with carboplatin-pemetrexed). LC10 tissue and plasma tests exhibited high concordance with CTAs. In addition, EGFR Ex20ins-patients identified by LC10 dual tests maintained the comparable clinical efficacy to PAPILLON full analysis set. Thus, this approved dual tissue and plasma CDx delivers comprehensive diagnostic solutions through distributable kits for NSCLC EGFR Exon20ins patients in China and beyond."

Clinical • Companion diagnostic • EGFR exon 20 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sintilimab plus platinum-based chemotherapy with vs without autologous CIK cell therapy in metastatic NSCLC: A multicenter randomized study (ESMO Asia 2025) - P2 | "Eligible patients (pts) were randomized (1:1) to receive four cycles of sintilimab plus chemotherapy with or without CIK cells for up to 8 cycles, maintained with sintilimab ± pemetrexed (for non-squamous) until progression or intolerable toxicity. This study demonstrated that the addition of CIK cells to chemo-immunotherapy significantly improved efficacy, along with manageable toxicity in advanced NSCLC, which provided a promising treatment regimen."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Reply to letter to the editor "The effectiveness of pembrolizumab maintenance with or without pemetrexed after induction treatment for advanced non-squamous Non-Small-Cell lung cancer". (PubMed, Lung Cancer) - No abstract available

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

Atezolizumab + Chemotherapy for Advanced Non-Small Cell Lung Cancer in Japanese Clinical Practice (J-TAIL-2). (PubMed, Cancer Sci) - P | "Patients ≥ 20 years old with NSCLC received atezolizumab plus carboplatin and nab-paclitaxel (atezo + CnP), atezolizumab plus carboplatin or cisplatin plus pemetrexed (atezo + PP), or atezolizumab plus bevacizumab plus carboplatin and paclitaxel (atezo + bev + CP) in clinical practice. No new safety signals were observed. Real-world efficacy and safety for each atezolizumab combination were comparable to those in the relevant IMpower trials."

Journal • Immunology • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Pemetrexed plus platinum outperforms other platinum-based adjuvant chemotherapy regimens for resected stage II-IIIA lung adenocarcinoma: an open-label, historical-control study. (PubMed, J Thorac Dis) - "In addition, we retrospectively collected the data from 209 patients recorded between January 2003 and December 2021 with pathologic stage II-IIIA lung adenocarcinoma who received radical surgery followed by adjuvant non-PEM (paclitaxel, gemcitabine and vinorelbine) plus platinum as historical control. Besides, AEs of all grades were reported more frequently in the non-PEM plus platinum group than in PEM based group, such as neutropenia (76.1% vs. 25.4%), anemia (48.3% vs. 8.5%) and thrombocytopenia (23.4% vs. 5.6%). This study showed that PEM plus platinum outperforms non-PEM plus platinum as an adjuvant chemotherapy regimen for resected stage II-IIIA lung adenocarcinoma and with better tolerability."

Journal • Hematological Disorders • Lung Adenocarcinoma • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia

Clinical case report on the efficacy and safety of savolitinib in elderly patients with non-small cell lung cancer harboring METex14 skipping mutations. (PubMed, Transl Cancer Res) - "They were treated with savolitinib as the second-line treatment after previously receiving AP regimens (pemetrexed + cisplatin). The case series demonstrated that savolitinib has a favorable clinical efficacy and safety profile, suggesting its potential as a key therapeutic option for elderly patients with NSCLC harboring METex14 skipping mutations. The treatment offers sustained survival benefits and is well-tolerated."

Journal • Breast Cancer • Cardiovascular • CNS Disorders • Hypertension • Lung Cancer • Movement Disorders • Non Small Cell Lung Cancer • Oncology • Parkinson's Disease • Solid Tumor • MET

A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: University of Utah | Trial completion date: Feb 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Feb 2025

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Extended Survival In A Patient With Leptomeningeal Disease Related To EGFR Exon 19 Deletion Metastatic Non-small Cell Lung Cancer: A Case Report (SNO 2025) - "She was initiated on Osimertinib...Despite treatment with stereotactic radiosurgery, she had further LMD progression, and another surgical resection was performed at 55 months, yet LMD recurred at 62 months, and she was enrolled in phase-2 WSD0922 clinical trial utilizing an oral brain-penetrant non-competitive reversible EGFR inhibitor with complete radiological resolution of LMD. At 73 months, she had LMD relapse and was initiated on intrathecal pemetrexed and intravenous amivantamab, and has thus far received 11 doses of intrathecal pemetrexed and amivantamab every two weeks with complete radiological response. At last follow-up, the patient is alive 82 months from her LMD diagnosis with excellent functional status. our case highlights that leveraging different mechanisms of action to target EGFR mutation in sequential fashion along with consideration of intrathecal chemotherapy in patients with LMD related to metastatic EGFR-mutated NSCLC can potentially help..."

Case report • Clinical • Metastases • Cough • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR