topotecan / Generic mfg. - LARVOL DELTA

Culture-Proven Haemophilus influenzae Endophthalmitis After Intravitreal Topotecan for Retinoblastoma. (PubMed, J Vitreoretin Dis) - "Urgent 23-gauge pars plana vitrectomy was performed to clear dense vitritis and maintain oncologic control using a closed-system approach, melphalan irrigation (5 µg/mL), IVT topotecan, port-site cryotherapy, and silicone oil tamponade. The patient also received IVT vancomycin, ceftazidime, and voriconazole...The infection resolved, the tumor continued to regress, and no extraocular tumor spread was observed during 24 months of follow-up. Early, tailored vitrectomy may help preserve vision in severe endophthalmitis after IVT chemotherapy for retinoblastoma when strict oncologic precautions are maintained, with long-term follow-up required to monitor for tumor recurrence or extraocular spread."

Journal • Eye Cancer • Infectious Disease • Influenza • Ocular Infections • Ocular Inflammation • Ocular Melanoma • Oncology • Ophthalmology • Respiratory Diseases • Retinal Disorders • Retinoblastoma • Solid Tumor

Targeting mitochondrial G-quadruplex DNA with a theragnostic small molecule for cervical Cancer imaging and therapy. (PubMed, Spectrochim Acta A Mol Biomol Spectrosc) - "In vivo, LN1 achieves selective tumor accumulation, enables high-contrast fluorescence imaging of xenografted tumors, and exhibits antitumor efficacy comparable to that of topotecan. By integrating diagnostic imaging and targeted anticancer activity within a single molecular framework, this work establishes a new paradigm for mitochondria-targeted theranostics and highlights mtG4 DNA as a clinically actionable vulnerability in cancer."

Journal • Cervical Cancer • Oncology • Solid Tumor • CASP3 • CASP7 • CASP9

Rapid Administration Pilot for Infusing Dinutuximab (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Children's Hospital Los Angeles | Phase classification: P1 ➔ P2 | N=11 ➔ 30 | Trial completion date: Jan 2026 ➔ Nov 2029 | Trial primary completion date: Jan 2026 ➔ Nov 2028

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Anti-B7-H3 ADCs Take Center Stage against SCLC at WCLC. (PubMed, Cancer Discov) - "Separate phase III trials of the anti-B7-H3 antibody-drug conjugates tambotatug pelitecan and risvutatug rezetecan significantly improved overall survival, progression-free survival, and objective response rates compared with topotecan in patients with relapsed small-cell lung cancer. In a third trial, the combination of the investigational PD-L1 x VEGF-A bispecific antibody pumitamig plus the anti-B7-H3 ADC elfetabart drozuntecan showed encouraging early efficacy in SCLC across lines of therapy and doses. The studies were presented at the 2026 World Congress on Lung Cancer in Seoul, Republic of Korea."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "Combination therapy with lurbinectedin plus doxorubicin did not improve overall survival versus control in patients with relapsed SCLC. However, lurbinectedin plus doxorubicin showed a favourable haematological safety profile compared with control."

Journal • P3 data • Hematological Disorders • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Olaparib as Treatment Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer: Phase III SOLO3 Study Final Overall Survival Results. (PubMed, J Clin Oncol) - P3 | "Two hundred sixty-six patients were randomly assigned 2:1 to olaparib tablets (300 mg twice daily; n = 178) or physician's choice of single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan; n = 88). BRCA reversion mutations might have contributed to this finding. No patient randomly assigned to olaparib with a BRCA reversion mutation detected at baseline (6 of 170 [3.5%]) achieved an objective tumor response."

Journal • P3 data • Oncology • Ovarian Cancer • Solid Tumor • BRCA

JSKN033 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=368 | Not yet recruiting | Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

New P3 trial • Cervical Cancer • Oncology • Solid Tumor

Tarlatamab as second-line (2L) treatment for small cell lung cancer (SCLC): Outcomes by chemotherapy-free interval (CFI) and prior PD-(L)1 inhibitor use in the phase III DeLLphi-304 trial (ESMO 2025) - P3 | "Methods Patients were randomised 1:1 to tarlatamab or CTx (topotecan, lurbinectedin, or amrubicin) Post hoc analysis was conducted for prespecified subgroups based on CFI (< 90 vs ≥ 90 days) and prior anti-PD-(L)1 use (yes vs no). Additionally, in contrast to CTx, the reduced risk of death and higher ORR with tarlatamab remained consistent even in platinum-resistant disease where prognosis has been especially poor, reinforcing tarlatamab as a standard of care for 2L SCLC. Table: LBA101 CFI Tarlatamab CTx Tarlatamab CTx < 90 days ≥ 90 days Efficacy n = 109 n = 114 n = 145 n = 141 Median OS, mos 10.9 6.4 17.1 10.6 HR (95% CI) 0.60 (0.43, 0.84) 0.65 (0.45, 0.93) Median PFS, mos 3.2 2.7 4.5 4.4 HR (95% CI) 0.71 (0.54, 0.94) 0.73 (0.56, 0.95) Safety n = 107 n = 109 n = 145 n = 135 Grade ≥ 3 TRAEs, % 30 58 24 66 TRAE leading to dose interruption or reduction, % 21 50 18 59 CRS, % 59 - 54 - Prior PD-(L)1 Yes No Efficacy n = 180 n = 180 n = 74 n = 75 Median OS, mos..."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. (PubMed, N Engl J Med) - P3 | "Treatment with tarlatamab led to longer overall survival than chemotherapy among patients with small-cell lung cancer whose disease had progressed during or after platinum-based chemotherapy. (Funded by Amgen; DeLLphi-304 ClinicalTrials.gov number, NCT05740566.)."

Journal • Cough • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Detailed safety analysis of DeLLphi-304: The first phase III study to evaluate tarlatamab versus chemotherapy for previously treated small cell lung cancer (ESMO 2025) - P3 | "Methods Pts were randomized to tarlatamab or chemotherapy (CTx: topotecan, lurbinectedin, or amrubicin). Conclusions In the DeLLphi-304 trial, tarlatamab demonstrated a predictable and manageable safety profile in 2L SCLC, with no new safety signals identified. Table: LBA100 Treatment-related adverse events TRAE Tarlatamab (n = 252) CTx (n = 244) All Grades Grade ≥3 All Grades Grade ≥3 Anemia 19.8% 2.0% 61.5% 27.9% Neutropenia 7.5% 4.4% 29.5% 22.1% Thrombocytopenia 3.2% 0.4% 23.8% 11.8% Infection 6.3% 1.2% 15.2% 8.6%"

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer • DLL3

Phase III assessment of topotecan and cyclophosphamide and high-dose ifosfamide in rEECur: An international randomized controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma (RR-ES). (ASCO 2022) - " Patients aged 4-50 with RR-ES were randomly assigned to topotecan and cyclophosphamide (TC), irinotecan and temolozomide (IT), gemcitabine and docetaxel (GD), or high-dose ifosfamide (IFOS). The first randomized trial in RR-ES has shown that high-dose ifosfamide is more effective in prolonging survival than TC, having previously beaten GD and IT, and should be considered as a control arm in future randomized phase II/III studies in RR-ES if combination with IFOS is logical. rEECur is the first study to provide comparative toxicity and survival data for the four most commonly used chemotherapy regimens in RR-ES."

Clinical • Late-breaking abstract • P3 data • CNS Disorders • Ewing Sarcoma • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Sarcoma • Solid Tumor

RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer. (PubMed, J Clin Oncol) - "Liposomal irinotecan and topotecan demonstrated similar median OS and PFS in patients with relapsed SCLC. Although the primary end point of OS was not met, liposomal irinotecan demonstrated a higher ORR than topotecan. The safety profile of liposomal irinotecan was consistent with its known safety profile; no new safety concerns emerged."

Journal • P3 data • Hematological Disorders • Leukopenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Tambotatug Pelitecan in Small-Cell Lung Cancer after Platinum-Based Therapy. (PubMed, N Engl J Med) - P3 | "Among patients with relapsed small-cell lung cancer after platinum-based therapy, treatment with tambotatug pelitecan resulted in longer overall survival, longer progression-free survival, and a higher percentage of patients with an objective response than treatment with topotecan, with a lower incidence of adverse events of grade 3 or higher. (Funded by the Innovative Drug Research and Development National Science and Technology Major Project and MediLink Therapeutics; TAISHAN-302 ClinicalTrials.gov number, NCT06612151.)."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Global Phase 2 Randomized Trial of BNT327 (Pumitamig; PD-L1 x VEGF-A bsAb) + Chemotherapy for 1L ES-SCLC: Dose Optimization Analysis (IASLC-WCLC 2025) - P2 | "Methods : In this global Phase 2, randomized, open-label,parallel group trial (NCT06449209), patients with treatment-naïve ES-SCLC received pumitamig+etoposide+carboplatin x 4 cycles followed by pumitamigmaintenance (Cohort 1); patients progressing after 1L or 2L treatment received pumitamig+paclitaxel(Cohort 2) or pumitamig+topotecan (Cohort 3). Pumitamig plus etoposide/carboplatin showed encouraging efficacy and acceptable safety in 1L ES-SCLC. This first presentation in a global population of a bispecific antibody targeting checkpoint inhibition and angiogenesis confirms the encouraging data previously reported in the 1L SCLC Chinese study (https://doi.org/10.1016/S1556-0864(25)00494-0).This dose optimization study supports further development of pumitamig in 1L SCLC,currently being evaluated in the ROSETTA Lung-01 Phase 3 trial."

Clinical • P2 data • Cardiovascular • Hypertension • Lung Cancer • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • PD-L1

A phase I/II multicenter, first-in-human study of DB-1311/BNT324 (a novel B7H3 ADC) in patients with advanced solid tumors (ESMO Asia 2024) - P1/2 | "In pts with SCLC (n=33), unconfirmed ORR was 45.5% with higher ORR in pts without prior topotecan (56.0%, n=25) or prior IO (55.6%, n=9). PRs were also observed in 3 pts with CRPC, 3 pts with NSCLC and 1 pt with BTC. Conclusions DB-1311/BNT324 had a manageable safety profile with low rates of G≥3 hematological events and promising antitumor activity, particularly in pts with advanced/metastatic SCLC."

Clinical • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer. (PubMed, N Engl J Med) - P3 | "Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response. (Funded by ImmunoGen; MIRASOL ClinicalTrials.gov number, NCT04209855.)."

Journal • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • FOLR1

Tazemetostat in combination with topotecan and pembrolizumab in patients with recurrent small cell lung cancer. (ASCO 2024) - P1 | "The study involves collection of mandatory biopsies at pre-treatment and post-treatment (cycle 1) to gain insights into mechanism of action and resistance of the combination using single cell and spatial transcriptomic approaches. For more questions regarding enrollment and eligibility please contact or ."

Clinical • Combination therapy • IO biomarker • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SLFN11 • TOP1

Sintilimab plus anlotinib as second or further-line therapy for small cell lung cancer: An objective performance trial. (ASCO 2022) - P2 | "The primary endpoint was the superiority of progression-free survival (PFS) versus a PFS of 2.8 months with historical topotecan control. Immunotherapy with sintilimab plus antiangiogenic drug anlotinib demonstrated promising antitumor activities as second or further-line therapy for ED-SCLC and had manageable toxicities. The findings support further development of this combination regimen for ED-SCLC."

Endocrine Disorders • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Comparing durvalumab, olaparib, and cediranib monotherapy, combination therapy, or chemotherapy in patients with platinum-resistant ovarian cancer with prior bevacizumab: the phase II NRG-GY023 trial. (PubMed, Clin Cancer Res) - "In PROC patients with prior bevacizumab, all experimental arms failed to reach the primary objective of improving PFS compared with SOC."

Journal • Monotherapy • P2 data • Platinum resistant • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Cediranib and Olaparib Combination Compared With Cediranib or Olaparib Alone, or Chemotherapy in Platinum-Resistant or Primary Platinum-Refractory Ovarian Cancer: NRG-GY005. (PubMed, J Clin Oncol) - "The cediranib-containing arms demonstrated clinical activity on the basis of PFS but were not superior compared with SOC."

Journal • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor

Safety and efficacy results in patients who received dose modifications in the phase III MIRASOL (GOG 3045/ENGOT-ov55) trial of mirvetuximab soravtansine vs investigator's choice chemotherapy (ICC) in platinum-resistant ovarian cancer (PROC) with high folate receptor-alpha expression (ESMO-GC 2024) - " 453 PROC pts with high FRα expression (VENTANA FOLR1 [FOLR1-2.1] RxDx Assay) with 1-3 prior therapies were randomized 1:1 to MIRV 6 mg/kg, adjusted ideal body weight, Day 1 of a 21-day cycle or ICC: paclitaxel, pegylated liposomal doxorubicin, or topotecan...In the MIRV arm, 36% had prior bevacizumab vs. 45% in the ICC arm, and 55% had prior PARPi vs 59% in the ICC... Dose modifications occurred at similar rates in both treatment arms. MIRV demonstrated a longer PFS, OS, and higher ORR vs ICC in patients with dose modifications. The efficacy data and the well-characterized safety profile support MIRV as the standard of care for pts with FRα positive PROC."

Clinical • P3 data • Gastrointestinal Disorder • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Intra-arterial chemotherapy for relapsing malignant gliomas. (EANO 2026) - "Tumour progression often occurs during or after standard first-line therapy comprised of radiotherapy with concomitant and adjuvant temozolomide...The following chemotherapeutic agents were used: carboplatin, melphalan, methotrexate, Caelyx, carboplatin + melphalan, carboplatin + methotrexate, carboplatin + etoposide phosphate or melphalan + methotrexate... Compared with published clinical trial results, our series data indicate that IAC is a promising treatment modality for relapsing malignant gliomas. We will gather more data and perform uni- and multivariate analyses. Moreover, we have initiated a randomized clinical trial to test the combination of carboplatin + etoposide phosphate and carboplatin + Caelyx in the treatment of relapsing GBM."

Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: BioNTech SE | Trial completion date: May 2028 ➔ Feb 2028

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). (ASCO 2024) - P3 | "After the investigators chose chemotherapy (CT) (weekly paclitaxel 80 mg/ m 2 d1, 8, 15 & 22 q4w, pegylated liposomal doxorubicin 40 mg/m 2 d1 q4w or topotecan 4 mg/m 2 d1, 8 & 15 q4w), patients were randomly assigned (2:1) to either Suvemcitug (1.5 mg/kg q2w) or placebo combine with CT until progression or unacceptable toxicity. To the best of our knowledge, this is the first double-blinded phase III study demonstrated promising antitumor activity of anti-angiogenic agent in patients with PROC. The improvement in PFS, ORR and DCR gained by adding Suvemcitug to single-agent CT was observed with no new safety concern."

Clinical • Late-breaking abstract • P3 data • Oncology • Ovarian Cancer • Solid Tumor

innovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator's choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer (ESMO 2023) - P3 | "Pts were randomized 1:1 to TV monotherapy or investigator's choice of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed...63.9% and 27.5% of pts had prior bevacizumab and prior anti-PD-(L)1 therapy, respectively...AEs were consistent with the known TV safety profile, including for ocular, peripheral neuropathy, and bleeding AEs. Conclusions In the phase 3 innovaTV 301 study, TV showed a statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs chemotherapy, with a manageable and tolerable safety profile in pts with 2L/3L r/mCC."

Clinical • Late-breaking abstract • Metastases • P3 data • Cervical Cancer • Oncology • Solid Tumor