Calsed (amrubicin) / Sumitomo Pharma, BMS, Nippon Kayaku - LARVOL DELTA

Network Meta-Analysis NMA of Clinical Effectiveness of Second-Line (2L+) Treatments in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ISPOR-EU 2025) - "DeLLphi-304, an ongoing phase III randomized controlled trial (RCT), showed that tarlatamab offers considerable clinical benefit in head-to-head comparisons versus chemotherapies (topotecan, amrubicin, or lurbinectedin). An NMA was conducted to indirectly compare tarlatamab with existing 2L treatments, including those not evaluated in DeLLphi-304. Bayesian NMAs using fixed effects models were used to compare overall survival (OS) and progression-free survival (PFS) among treatments in the overall 2L population (tarlatamab, topotecan, cyclophosphamide + doxorubicin + vincristine [CAV], amrubicin, and irinotecan-based regimens) and the platinum-sensitive (defined as chemotherapy-free interval ≥ 90 days) subgroup (tarlatamab, topotecan, platinum rechallenge, amrubicin, and liposomal irinotecan). In the overall 2L population, tarlatamab demonstrated significant improvements in OS compared to all comparators, with hazard ratios (HRs) ranging from 0.50 (95% credible interval..."

Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Indirect Comparison of Tarlatamab vs. Chemotherapy (CTx) in Patients With Previously Treated, Platinum-Refractory, or Resistant Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ISPOR-EU 2025) - P2, P3 | "OBJECTIVES: Tarlatamab showed considerable benefit in response, survival, and patient-reported outcomes compared to CTx (topotecan, lurbinectedin, or amrubicin) in ES-SCLC after first-line platinum-based therapy in the DeLLphi-304 trial (NCT05740566). While paclitaxel and cyclophosphamide/doxorubicin/vincristine (CAV) are treatment options for platinum-refractory or resistant ES-SCLC, there is a lack of head-to-head data comparing these treatments with tarlatamab... Tarlatamab offers significant efficacy benefit relative to paclitaxel and CAV in patients with platinum-refractory or resistant ES-SCLC in the second-line setting. These findings reinforce tarlatamab as an effective treatment option for this population."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Three Cases of Amrubicin Administration as Second-or Third-Line Chemotherapy for Primary Small Cell Carcinoma of the Prostate (PubMed, Hinyokika Kiyo) - "Case 1 : A 54-year-old male received cisplatin and irinotecan but showed metastatic progression...He received carboplatin-etoposide and then carboplatin-irinotecan...He passed away 36 months after starting treatment. Amrubicin may be a therapeutic option for primary SCC of the prostate, but achieving prolonged survival remains difficult."

Journal • Oncology • Prostate Cancer

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

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

IDeate-Lung02: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=540 | Active, not recruiting | Sponsor: Daiichi Sankyo | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Brain Atrophy and Leukoencephalopathy Following Tarlatamab: Case Report. (PubMed, Respirol Case Rep) - "Initially, she received carboplatin, etoposide and atezolizumab, followed by amrubicin as second-line treatment and nogitecan as third-line treatment...Dexamethasone was initiated without neurological improvement. The early-onset cerebral atrophy and leukoencephalopathy in the current case was attributed to whole brain radiotherapy and tarlatamab. Patients with brain metastases may be at increased risk of neurological events associated with tarlatamab."

Journal • CNS Disorders • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Intracranial activity of ifinatamab deruxtecan (I DXd) in patients (pts) with extensive-stage (ES) small cell lung cancer (SCLC) and baseline (BL) brain metastases (BM): Primary analysis of IDeate-Lung01 (JADPRO 2025) - P2, P3 | "BACKGROUND • Approximately 10-20% of patients with SCLC have BM at diagnosis, increasing to 80% after 2 years** -For patients with BM at baseline, median OS from time of diagnosis is ~5 months, with a 3-year survival rate of 3.0% In the primary analysis of IDeate-Lung01 (Phase 2; NCT05280470), I-DXd 12 mg/kg Q3W demonstrated a systemic CORR of 48.2%, mDOR of 5.3 months, and mPFS of 4.9 months in 137 patients with previously treated ES-SCLC METHODS • We report a subgroup analysis of patients with asymptomatic (previously treated or untreated) BM identified by CNS BICR at study baseline delectable by CT/MRI brain scan at baseline (Figure 1) • Brain CT/MRI was performed at baseline for all patients, and for those with investigator-determined BM, Q6W for 36 weeks and Q12W thereafter Intracranial response was assessed by CNS BICR using a version of RECIST 1.1 modified for assessment of CNS tumors RESULTS • Baseline characteristics of patients with baseline BM: -..."

Clinical • Brain Cancer • CNS Tumor • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Patient-reported outcomes (PROs) from DeLLphi-304: The first phase III trial evaluating tarlatamab and chemotherapy (CTx) in patients (Pts) with previously treated small cell lung cancer (SCLC) (ESMO 2025) - P3 | "Methods Pts were randomized to receive tarlatamab or CTx (topotecan, lurbinectedin or amrubicin) until disease progression. Conclusions Tarlatamab treatment delayed deterioration in cancer-related symptoms with a favorable benefit-risk profile and clinically meaningful improvements in quality of life. These findings reinforce tarlatamab as the new standard of care."

Clinical • P3 data • Patient reported outcomes • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Prognostic biomarkers for extensive-stage small cell lung cancer receiving amrubicin following failure of chemoimmunotherapy: a retrospective cohort study. (PubMed, Transl Lung Cancer Res) - "Multivariate analysis demonstrated that the NLR was an independent prognostic factor for predicting worse PFS and OS after AMR administration. NLR was identified as a significant biomarker for predicting AMR outcomes after prior CTI in patients with ES-SCLC."

Biomarker • IO biomarker • Journal • Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

IDeate-Lung02: a Phase 3 study of second-line ifinatamab deruxtecan in patients with relapsed small cell lung cancer. (PubMed, Future Oncol) - P3 | "Patients with small cell lung cancer (SCLC) have poor prognosis and limited treatment options beyond first-line therapy. Secondary endpoints include ORR by investigator; progression-free survival, duration of response, disease control rate, and time to response, all by BICR and investigator; patient-reported outcomes; and safety. IDeate-Lung02 will ascertain whether I-DXd treatment after only one prior line of systemic treatment improves outcomes for patients with relapsed SCLC compared with topotecan, amrubicin, or lurbinectedin.Clinical Trial Registration: NCT06203210."

Journal • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Real-World Clinical Outcomes of Patients With Masaoka Stage Iv Thymic Carcinoma Treated With Carboplatin and Paclitaxel (IASLC-WCLC 2025) - "As second-line chemotherapy, lenvatinib was administered in 5 patients, amrubicin in 6, S-1 in 3, and other regimens in 10. Conclusions : This study demonstrated the CP regimen is relatively effective for Masaoka IV stage thymic carcinoma patients. Among the patients who relapsed after the CP regimen, a high proportion of the patients (92%) were able to proceed the subsequent chemotherapy."

Clinical • Clinical data • Metastases • Real-world • Real-world evidence • Neuroendocrine Tumor • Oncology • Solid Tumor • Squamous Cell Carcinoma • Thymic Carcinoma • Thymus Cancer

A Phase 3 Study of Sacituzumab Govitecan in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (IASLC-WCLC 2025) - P3 | "EVOKE-SCLC-04 (NCT06801834) is a global, multicenter, randomized, open-label, phase 3 study evaluating the efficacy and safety of SG versus SOC (topotecan or amrubicin [Japan only]) in previously treated patients with ES-SCLC. Secondary endpoints include progression-free survival, duration of response, patient-reported outcomes (time to first deterioration in shortness of breath and physical functioning), and safety/tolerability. This study is open and actively recruiting as of February 2025 and is planning to enroll 695 patients from approximately 200 sites globally."

Clinical • P3 data • CNS Disorders • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Amrubicin monotherapy for refractory, relapsed, small cell lung cancer in elderly patients. (PubMed, Jpn J Clin Oncol) - "Both hematological and non-infectious adverse events may have contributed to shorter progression-free survival in the high-dose group. Low-dose administration, granulocyte colony-stimulating factor support, and close monitoring for non-infectious toxicities may be important in elderly patients."

Journal • Monotherapy • Cardiovascular • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Myocardial Infarction • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

DeLLphi-304: Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=509 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Jul 2027 ➔ Mar 2028

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

Long-term survival with multimodal treatment including conversion surgery for locally advanced esophageal neuroendocrine carcinoma: A case report. (PubMed, World J Gastrointest Surg) - "This case highlights the potential of multimodal treatment for long-term survival in advanced esophageal NEC."

Journal • Endocrine Cancer • Hepatocellular Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor • Squamous Cell Carcinoma

Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304. (ASCO 2025) - P3 | "The DeLLphi-304 trial showed tarlatamab significantly improved OS, PFS, and PROs, with a favorable safety and tolerability profile compared to CTx in pts with SCLC that progressed on or after initial platinum-based CTx, defining a new standard of care for these patients. Clinical Trial Information: NCT05740566; Legal entity responsible: Amgen Inc.; Funding: Amgen Inc.; Editorial acknowledgement: Medical writing support for the development of this abstract was provided by Sukanya Raghuraman, PhD, of Cactus Life Sciences, part of Cactus Communications, and was funded by Amgen Inc. MD: mean difference; NE: not estimable; wks, weeks.*Topotecan (n=185), lurbinectedin (n=47), or amrubicin (n=23).†EORTC QLQ-C30 scale.‡EORTC QLQ-LC13 scale.§Non-significant."

Clinical • Late-breaking abstract • Anemia • Cough • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • 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

DeLLphi-304: Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=509 | Active, not recruiting | Sponsor: Amgen | Trial primary completion date: Jul 2027 ➔ Jan 2025

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

EVOKE-SCLC-04: Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=695 | Recruiting | Sponsor: Gilead Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy of second line and subsequent treatments of small cell lung cancer with and without immune checkpoint inhibitor combination therapy. (PubMed, Respir Investig) - "In ES-SCLC, there is no significant additive effect on PFS and OS of second- and subsequent line treatments following ICI-chemo at first-line treatment."

Checkpoint inhibition • Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Amrubicin Monotherapy After Chemoradiotherapy in Patients With Relapsed Limited Disease Small-cell Lung Cancer. (PubMed, Anticancer Res) - "Amrubicin is both feasible and effective in patients with relapsed SCLC who were previously treated with CRT. The efficacy and toxicity of amrubicin in this study were consistent with those of previous reports, indicating that amrubicin retained its effectiveness post-CRT. Consequently, amrubicin following CRT may be the optimal chemotherapeutic choice for patients with relapsed limited-disease SCLC."

Journal • Monotherapy • Retrospective data • Febrile Neutropenia • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Systemic treatment for patients with advanced Merkel cell carcinoma in Japan: A multicenter retrospective study (ESMO Asia 2024) - "Thirteen patients received chemotherapy as second-line therapy after avelumab, including seven patients with carboplatin plus etoposide, three patients with cisplatin plus etoposide, one patient with carboplatin, one patient with cyclophosphamide plus adriamycin plus vincristine, and one patient with amrubicin. A common grade 3 or greater adverse event associated with avelumab was infusion reaction (4.0%), and those associated with chemotherapy were neutrophil count decreased (47.1%), including febrile neutropenia (23.5%). Conclusions First-line avelumab for patients with MCC in Japan showed favorable efficacy and durability, but developing second-line therapy after avelumab is required."

Metastases • Retrospective data • Endocrine Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Real-world treatment patterns and survival in extensive stage small-cell lung cancer in Japan. (PubMed, Jpn J Clin Oncol) - "Anti-PD-L1 therapies have become part of first-line standard of care but survival in treated Japanese ES-SCLC patients remains poor, highlighting the unmet medical need in the post anti-PD-L1 era."

HEOR • Journal • Real-world • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ESMO 2024: Targeting the Treatment Challenges of Small Cell Lung Cancer : Episode 10: Comparing Treatment Schedules: Ifinatamab Deruxtecan vs Amrubicin, Topotecan, and Lurbinectedin in SCLC (OncLive) - "Panelists discuss how the treatment schedule of ifinatamab deruxtecan at 12 mg/kg intravenouslyIV Q3W once every 3 weeks may compare favorably to established regimens like amrubicin, topotecan, and lurbinectedin for relapsed small cell lung cancer, while also exploring potential dose adjustments, immunogenicity concerns, and the synergistic effects when combined with atezolizumab and carboplatin."

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