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

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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Candida Epiglottitis in a Patient Undergoing Chemotherapy for Small Cell Lung Cancer: A Case Report. (PubMed, Cureus) - "On the 10th day after receiving amrubicin and pegfilgrastim, he developed fever and a sore throat, presenting to the clinic the following day...The patient was hospitalized and treated with intravenous micafungin and meropenem, along with amphotericin B gargles...Antifungal therapy was completed within 11 days of hospitalization. This case underscores the importance of considering Candida epiglottitis in immunocompromised patients presenting with a sore throat, as prompt diagnosis and treatment are essential to prevent potentially fatal complications."

Journal • Chronic Obstructive Pulmonary Disease • Febrile Neutropenia • Hematological Disorders • Immunology • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Randomized Phase II Trial of Amrubicin Plus Irinotecan Versus Cisplatin Plus Irinotecan in Chemo-naïve Patients With Extensive-Disease Small-Cell Lung Cancer: Results of the Japan Multinational Trial Organization (JMTO) LC 08-01. (PubMed, Clin Lung Cancer) - "Although the study did not meet its primary endpoint, AI showed promising efficacy and good tolerability in chemo-naïve patients with ED-SCLC."

Journal • P2 data • Anorexia • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

A Case Report of Primary Neuroendocrine Carcinoma of the Anal Canal with Cancer Genome Profiling. (PubMed, Intern Med) - "Despite the standard first-line treatment with etoposide or irinotecan combined with cisplatin, effective second-line therapies are lacking...We present the case of a 79-year-old woman with NEC of the anal canal, treated with etoposide, carboplatin, and amrubicin. Post-standard therapy, CGP suggested pemigatinib, a tyrosine kinase inhibitor; however, the patient died before receiving it. This case highlights the potential of personalized medicine to improve outcomes in such cases."

Journal • Anal Carcinoma • Endocrine Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Chemotherapy Sensitivity for Recurrent Small-Cell Lung Cancer Based on Chemotherapy-Free Interval and Treatment Regimens (IASLC-WCLC 2024) - "The concept of sensitive relapse was established before the advent of amrubicin (available in Japan) and lurbinectedin (recommended in ESMO and NCCN guidelines), which are effective for recurrent SCLC...Thirty-four were treated by platinum-doublet re-challenge, and 29 received monotherapy of amrubicin, topotecan, or irinotecan...It is still unclear whether the response of second-line chemotherapy following ICI is elevated compared to conventional chemotherapy. Further investigation is needed."

Lung Cancer • Oncology • 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 | Recruiting ➔ Active, not recruiting

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

A Case of Successful Treatment of Small Cell Carcinoma of the Bladder with Pembrolizumab (PubMed, Hinyokika Kiyo) - "Similar to small cell lung cancer, platinum-based chemotherapy is recommended as the first-line therapy, and amrubicin (AMR) is recommended as the second-line therapy, but there is no established therapy after the second line...A 77-year-old male, diagnosed with clinical stage T3N0M0 small cell carcinoma and invasive urothelial carcinoma by transurethral resection of bladder tumor (TURBT), underwent robot-assisted radical cystectomy after three cycles of neoadjuvant cisplatin-irinotecan chemotherapy, and pathological examination revealed only small cell carcinoma in his cystectomy specimen. After three courses of adjuvant carboplatin-etoposide chemotherapy, the patient developed liver and bone metastases...Metastases decreased after starting pembrolizumab and continued to decrease after discontinuation because of immunerelated adverse events (irAEs). Therefore, pembrolizumab may be an option for the treatment of refractory SCCB."

Journal • Bladder Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Urethral Cancer • Urothelial Cancer

A Case of Rapidly Progressing Breast Neuroendocrine Carcinoma (JBCS 2024) - "Preoperative chemotherapy was performed with dose-dense AC therapy as in breast cancer, but the tumor and axillary lymph nodes grew, so cisplatin (CDDP) + etoposide (VP-16) was then administered as in NEC...After surgery, chemotherapy with cisplatin (CDDP) + irinotecan (CPT-11) was selected as in the case of NEC, but 4 months after surgery, the patient relapsed with multiple liver metastases and left interpectoral lymph node metastases. Amrubicin (AMR) was administered as a refractory relapse in recurrent small cell lung cancer, but the metastatic lesions grew, and subcutaneous nodules and lymph node metastases in the subclavian, pericardiophrenic angle, and around the hepatic artery appeared. As the patient was PD-L1 positive, pembrolizumab (PEM) + gemcitabine (GEM) + carboplatin (CBDCA) was administered, but the patient died 7 months after surgery due to rapid progression of the metastatic lesions. There is no established treatment for NEC, so it is desirable to..."

Clinical • Breast Cancer • Endocrine Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • ER • HER-2 • PD-L1 • PGR

IDeate-2: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=468 | Recruiting | Sponsor: Daiichi Sankyo | Not yet recruiting ➔ Recruiting

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

A Case of Small Cell Carcinoma of the Urethra (PubMed, Hinyokika Kiyo) - "Four courses of chemotherapy with etoposide and cisplatin, followed by 66 Gy of irradiation achieved complete remission...Although seven courses of chemotherapy with nogitecan were carried out, a new metastatic bone tumor developed. Amrubicin was administered as a third-line treatment, but was canceled after one course because of side effects. The patient died at 39 months after diagnosis. Small cell carcinoma of urethra with metastases has extremely poor prognosis, as is demonstrated by this case."

Journal • Oncology • Osteosarcoma • Solid Tumor • Urethral Cancer

IDeate-Lung02: A phase 3, randomized, open-label study of ifinatamab deruxtecan (I-DXd) vs treatment of physician's choice (TPC) in relapsed small cell lung cancer (SCLC). (ASCO 2024) - P1/2, P2, P3 | "Pts are randomized 1:1 to receive I-DXd 12 mg/kg iv every 3 wks (n = 234) or TPC (n = 234; topotecan, amrubicin, or lurbinectedin). Immunogenicity of I-DXd and relationship between B7-H3 expression and clinical outcome are also secondary objectives. ORR will be analyzed using a Cochran-Mantel-Haenszel test at a 2-sided 1% alpha level, and OS will be analyzed using a log-rank test at a 2-sided 4% significance level, under a 2-look group sequential design."

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

A multicenter retrospective study of ramucirumab-containing chemotherapy for gastrointestinal neuroendocrine carcinoma after platinum-based chemotherapy (WJOG13420G: RAM-NEC) (ESMO-GI 2024) - "RAM was often combined with weekly paclitaxel in G-NEC (65%) and FOLFIRI in C-NEC (70%). In the Non-RAM group, 65% of G-NEC pts and 53% of C-NEC pts received amrubicin as second-line CTx... RAM-containing CTx after platinum-based CTx may be effective for gastrointestinal NEC, especially G-NEC."

Retrospective data • Endocrine Cancer • Gastrointestinal Disorder • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Treatment outcomes of amrubicin monotherapy for patients with advanced hepatobiliary and pancreatic neuroendocrine carcinoma (ESMO-GI 2024) - "The efficacy of AMR monotherapy in HBP NEC was modest, with a high incidence of neutropenia. The developments of other therapeutic regimens for HBP NEC are needed."

Clinical • Metastases • Monotherapy • Endocrine Cancer • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Pancreatic Cancer • Pneumonia • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Simultaneous Acquisition of T790M Mutation and SCLC Transformation during Targeted Therapy in EGFR-Mutated Lung Adenocarcinoma: A Rare Case Report. (PubMed, Am J Case Rep) - "During treatment with erlotinib, the patient developed SCLC and adenocarcinoma with EGFR exon 21 L858R and exon 20 T790M mutation...The patient received 4 cycles of carboplatin plus etoposide, 14 cycles of amrubicin, and 2 cycles of irinotecan...CONCLUSIONS Long-term survival was achieved by chemotherapy after transformation. Since EGFR mutation-positive lung cancer shows a variety of acquired resistances, it is important to consider the treatment strategy of performing re-biopsy."

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

IDeate-2: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=468 | Not yet recruiting | Sponsor: Daiichi Sankyo | Trial completion date: Jan 2028 ➔ Feb 2029 | Trial primary completion date: Jul 2026 ➔ Apr 2027

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

Efficacy of second-line chemotherapy in patients with pulmonary large cell neuroendocrine carcinoma. (PubMed, Sci Rep) - "In patients treated with amrubicin, the PFS (P = 0.964) and OS (P = 0.544) were not different between both the groups. Second-line chemotherapy, including amrubicin, may be considered as a treatment option for patients with pulmonary LCNEC."

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

Multidisciplinary treatment for small cell carcinoma of the bladder: a case report. (PubMed, Int Cancer Conf J) - "After systemic chemotherapy using etoposide and carboplatin and subsequent TURBT, a radical cystectomy and ileal conduit were performed...Systemic combination chemotherapy with carboplatin plus irinotecan (CBDCA + CPT-11) was administered, followed by amrubicin and an immune checkpoint inhibitor...The patient survived for 2 years after the initial diagnosis. Our report indicates that multidisciplinary treatment can be effective for SCC of the bladder, and a therapeutic strategy including the identification of novel biomarkers should be established."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Pain • Solid Tumor • Urethral Cancer