albumin-bound paclitaxel / Generic mfg. - LARVOL DELTA

Meitheal Pharmaceuticals Announces Launch of Generic Paclitaxel Formulation in the United States Through Exclusive Commercial Licensing Agreement (Businesswire) - "Meitheal Pharmaceuticals...announced it has launched, through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. ('HKF'), paclitaxel protein-bound particles for injectable suspension (albumin-bound), a generic form of Abraxane, in the U.S. The 100mg/vial single-dose presentation of protein-bound paclitaxel for injectable suspension is indicated for the treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas, and locally advanced or metastatic non-small cell lung cancer."

Generic launch • Licensing / partnership • Breast Cancer • Non Small Cell Lung Cancer • Pancreatic Adenocarcinoma

The Role of Nanoparticles in Therapy of Real-World Patients with Pancreatic Cancer: A Scoping Review. (PubMed, Cancers (Basel)) - "Pancreatic cancer (PC) is one of the most aggressive and fatal malignancies worldwide, posing a significant global health challenge due to its high mortality rates, late-stage diagnosis, and limited therapeutic efficacy [...]."

Journal • Real-world evidence • Review • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Role of pelareorep in activating anti-tumor immunity in PDAC. (ASCO 2025) - "We previously reported high tumor response rates in first-line metastatic PDAC patients treated with pela combined with gemcitabine, nab-paclitaxel and atezolizumab. These findings, while preliminary, demonstrate that pela induces not only anti-reovirus T cells but also activates innate and adaptive anti-tumor immunity in PDAC subjects treated with chemotherapy and atezolizumab. Tumor responses are associated with both the presence of TIL clones in the blood prior to treatment and the expansion of pre-existing TILs in the blood on treatment. These findings provide additional insights into the immunologic mechanisms by which pela-based therapy may provide clinical benefit in patients with metastatic PDAC."

IO biomarker • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CXCL10 • CXCL11 • CXCL9 • IFNG • PD-L1

Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004) (clinicaltrials.gov) - P2 | N=29 | Not yet recruiting | Sponsor: West China Hospital

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

Humanistic Burden in Metastatic Triple-Negative Breast Cancer (mTNBC): A Systematic Literature Review (SLR) (ISPOR 2025) - "Studies in anti-PD-(L)1 therapy eligible patients : These 4 studies compared atezolizumab+nab-paclitaxel versus placebo+nab-paclitaxel, pembrolizumab+chemotherapy versus placebo+chemotherapy, pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab+olaparib versus pembrolizumab+chemotherapy...One study showed HRQOL improvement and utility gains in later-line mTNBC for sacituzumab govitecan versus placebo/TPC... Newer therapies for mTNBC, including immunotherapy, showed no detriment or modest HRQOL benefit over comparators via exploratory analyses. More data are needed to better understand the humanistic burden of mTNBC on patient HRQOL, especially in the advanced/metastatic setting."

IO biomarker • Metastases • Review • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA

Two cycles of neoadjuvant therapy with low-dose radiotherapy, PD-1 inhibitor tislelizumab, albumin-bound paclitaxel, and cisplatin for resectable locally advanced head and neck squamous cell carcinoma (NeoRTPC02): A phase II, open-label, single-arm trial. (ASCO 2025) - P2 | "Neoadjuvant LDR combined with tislelizumab, albumin-bound paclitaxel, and cisplatin resulted in an impressive pCR rate and demonstrated promising efficacy with manageable toxicity in patients with resectable LA HNSCC. Long-term survival data are still follow-up."

Clinical • Metastases • P2 data • Head and Neck Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

The preliminary efficacy and safety results of neoadjuvant phase II study of anlotinib plus tislelizumab combined with chemotherapy in triple-negative breast cancer. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT04914390 Background: The KEYNOTE-522 trial demonstrated that adding pembrolizumab to chemotherapy improves the pathologic complete response (pCR) rate and survival in triple-negative breast cancer (TNBC)...Patients received 5 cycles of anlotinib (8 mg qd, d1-14; 21 days per cycle) with 6 cycles of tislelizumab (200 mg, once every 3 weeks) plus nab-paclitaxel (260 mg/m2, once every 3 weeks) and anthracycline (epirubicin 75 mg/m2 or doxorubicin 60 mg/m2), followed by surgery... The preliminary results demonstrated that anlotinib plus tislelizumab and chemotherapy as neoadjuvant therapy for TNBC showed promising antitumor efficacy and manageable safety profile. The study is still ongoing. Clinical trial information: NCT04914390."

Clinical • IO biomarker • P2 data • Anemia • Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Neoadjuvant chemoimmunotherapy with afatinib for locally advanced head and neck squamous cell carcinoma (neoCHANCE-2): An open-label, single-arm, phase 2 study. (ASCO 2025) - P2 | "Patients with LA-HNSCC received two cycles of tislelizumab (200mg) and TP (nab-paclitaxel and cisplatin) chemotherapy, administrated on day one of each three-week cycle, along with afatinib (30mg) during the intermittent period between chemoimmunotherapy cycles, followed by 15 cycles of adjuvant tislelizumab treatment. This study firstly reported the promising efficacy and acceptable safety profile of neoadjuvant chemoimmunotherapy combined with apatinib in the treatment of patients with LA-HNSCC. Further evaluation in large-scale clinical trials with longer follow-up periods is needed."

Clinical • IO biomarker • Metastases • P2 data • Alopecia • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

Neoadjuvant with low-dose radiotherapy, tislelizumab, albumin-bound paclitaxel, and cisplatin for resectable locally advanced head and neck squamous cell carcinoma: phase II single-arm trial. (PubMed, Nat Commun) - P2 | "Single-cell RNA sequencing revealed remodeling of the HNSCC tumor microenvironment, which may correlate with improved clinical outcomes. This trial met the pre-specified primary endpoint, demonstrating a high pCR rate with promising efficacy and manageable toxicity in locally advanced HNSCC."

Journal • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Use of low-value cancer treatments in Medicare Advantage versus traditional Medicare. (ASCO 2025) - " Using national Medicare data, we performed retrospective analyses of beneficiaries who had a new cancer diagnosis between 2016 and 2021, and who were at risk of receiving one of the following low-value treatments: growth factors (GCSF) for patients receiving low-risk chemotherapy; denosumab for castration sensitive prostate cancer (CSPC); nab-paclitaxel instead of paclitaxel for breast or lung cancers; adding bevacizumab to carboplatin + paclitaxel for ovarian cancer; and branded drugs or biologics for which generic or biosimilar versions existed. For Medicare beneficiaries at risk of receiving a low-value cancer treatment, MA enrollees were less likely to receive low-value cancer treatments than TM beneficiaries. These reductions in low value services may prevent avoidable toxicity and lower treatment cost to the patient and health care system. Increased efforts are needed to identify approaches that MA plans use to reduce low-value cancer treatments, and explore ways..."

Medicare • Reimbursement • US reimbursement • Breast Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

neoCHANCE-2: Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for HNSCC (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: West China Hospital | Recruiting ➔ Completed | N=28 ➔ 40 | Trial completion date: Aug 2024 ➔ Dec 2024

Enrollment change • Trial completion • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A retrospective pilot study of neoadjuvant chemotherapy combined with immunotherapy in the treatment of thoracic esophageal squamous cell carcinoma with cervical lymph node metastasis. (ASCO 2025) - "19 patients received camrelizumab, nab-paclitaxel, and S-1 regimen and 1 received tislelizumab, nab-paclitaxel and nedaplatin regimen. With manageable safety profiles, high pathological response rates and enhanced survival rates, neoadjuvant CIT shows significant potential for improving clinical outcomes in ESCC and CLNM. Further prospective trials are needed to fully evaluate the effectiveness and safety of this treatment strategy for these patients. Baseline Characteristics of the Patients"

Retrospective data • Anemia • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Squamous Cell Carcinoma

Adaptive Neoadjuvant Therapy for Esophageal Cancer (clinicaltrials.gov) - P=N/A | N=43 | Enrolling by invitation | Sponsor: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

New trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology

Efficacy, safety and exploratory analysis of neoadjuvant tislelizumab (a PD-1 inhibitor) plus nab-paclitaxel followed by epirubicin/cyclophosphamide for triple-negative breast cancer: a phase 2 TREND trial. (PubMed, Signal Transduct Target Ther) - P2 | "In conclusion, neoadjuvant treatment of tislelizumab with nab-paclitaxel and anthracycline-based chemotherapy showed promising clinical activity and was well-tolerated among TNBC patients, without high incidence of TRAEs. These findings provide evidence supporting neoadjuvant tislelizumab with chemotherapy as an effective rational approach for treating TNBC."

Journal • P2 data • Alopecia • Breast Cancer • Hepatology • Immunology • Liver Failure • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • CDKN1A

SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Peking University Shenzhen Hospital

Biomarker • New P2 trial • Oncology

Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

An exploratory study of neoadjuvant tislelizumab combined with TP regimen for the comprehensive treatment of resectable locally advanced oral squamous cell carcinoma. (ASCO 2025) - P2 | " In this exploratory study, eligible patients with untreated locally advanced, resectable OSCC (T3-4bN0-3M0; stage III-IVb, AJCC 8th Edition) were enrolled to receive Tislelizumab (200mg) and platinum-doublet chemotherapy[albumin-bound paclitaxel (240 mg/m2) plus cisplatin (70 mg/m2)] on day 1 Q3W for three cycles, followed by surgery and postoperative adjuvant therapy. The current findings, along with acceptable safety and reduction in the extent of surgery, suggests that tislelizumab combined with TP regimen represents a potential treatment for LA OSCC. But the evaluation of response and long-term efficacy is still needed collected and follow-up."

Clinical • Metastases • CNS Disorders • Fatigue • Gastrointestinal Disorder • Insomnia • Oncology • Oral Cancer • Pain • Sleep Disorder • Squamous Cell Carcinoma

A single-center, prospective, randomized controlled trial of tislelizumab combined with platinum-containing chemotherapy as first-line treatment for HIV-positive patients with advanced non-small cell lung cancer. (ASCO 2025) - "All patients received tislelizumab combined with platinum-containing chemotherapy (paclitaxel or nab-paclitaxel or pemetrexed combined with cisplatin or carboplatin) for 4-6 cycles, followed by maintenance therapy with tislelizumab until disease progression or intolerable toxicities. The efficacy and safety of tislelizumab combined with chemotherapy for HIV-positive patients with advanced NSCLC is comparable to that of non-HIV advanced NSCLC patients. However, HIV-positive patients are more susceptible to opportunistic infections and require closer management throughout the course of treatment. The study is ongoing and requires further follow-up."

Clinical • Metastases • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Camrelizumab in Combination With Cetuximab and Chemotherapy for Relapsed/Metastatic HNSCC Patients (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Fudan University | Trial completion date: Mar 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Mayo Clinic | Suspended ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Envafolimab combined with albumin-bound paclitaxel and cisplatin in the neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma: A prospective, single-arm, multicenter phase II study. (ASCO 2025) - P2 | "The combination of envafolimab, albumin-bound paclitaxel and cisplatin demonstrates promising pCR rate and acceptable tolerance in patients with LA-ESCC. The trial is ongoing, with further investigation anticipated."

Clinical • Metastases • P2 data • Cerebral Hemorrhage • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

First-line envafolimab in combination with recombinant human endostatin and chemotherapy for advanced squamous non-small cell lung cancer: Updated results from a prospective, single-arm, multicenter phase II study. (ASCO 2025) - P2 | "Patients received Envafolimab (300 mg, subcutaneously, day 1) and Rh-endostatin (210 mg, continuous intravenous infusion over 72 hours, day 1-3) combined with paclitaxel (175mg/m2, day 1) or albumin paclitaxel (260 mg/m2, day 1), and cisplatin (75 mg/m2 , day 1-3), or carboplatin ( AUC 5, IV, day 1); every 3 weeks for 4-6 cycles, followed by maintenance Envafolimab until disease progression (PD), unacceptable toxicity, or patient refusal... Our results demonstrated that Envafolimab in combination with Rh-endostatin and chemotherapy resulted in favorable clinical outcomes with a manageable safety profile, representing a promising treatment modality as first-line therapy for advanced sq-NSCLC."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Alopecia • Immunology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase II study of neoadjuvant GVAX and cyclophosphamide combined with nivolumab and SBRT followed by surgery in borderline resectable pancreatic adenocarcinoma. (PubMed, Clin Cancer Res) - "The addition of combined immunotherapy and SBRT was safe and feasible in this patient population. No difference was observed in the mean CD8 T cell density between study patients and historical controls. These findings support the need for better characterization of how neoadjuvant immunotherapy may shift the phenotype of the PDAC TME."

Journal • P2 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CD8 • CSF2

Sintilimab + Nab-PP Combined with Recombinant Human Vascular Endothelial Inhibitor for Locally Advanced/Advanced and Recurrent Metastatic Squamous Non-Small Cell Lung Cancer: Study Protocol for a Single-Arm, Multi-Centre Phase II Clinical Study. (PubMed, Technol Cancer Res Treat) - "Patients will receive endostar (210 mg/dose, 72 h), sintilimab (200 mg/dose), and chemotherapy (nab-pp, carboplatin/cisplatin + albumin-bound paclitaxel) every 3 weeks for up to 6 cycles, followed by maintenance therapy until progression or intolerable toxicity. Radiological assessments will occur every 8 weeks initially, then every 12 weeks. Biomarker analysis and quality of life assessments will be performed."

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

Locally advanced pancreatic adenocarcinoma in complete response after systemic chemotherapy. (PubMed, Rev Esp Enferm Dig) - "Chemotherapy with gemcitabine and nab-paclitaxel was initiated, with excellent clinical tolerance. A particular molecular sensitivity to treatment is suspected. This case underscores the need for improved early diagnosis and personalized therapeutic approaches."

Journal • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer