albumin-bound paclitaxel / Generic mfg. - LARVOL DELTA

RASolute 302: Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov) - P3 | N=501 | Active, not recruiting | Sponsor: Revolution Medicines, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Ivonescimab for EGFR-mutant lung adenosquamous carcinoma after multiline therapy: A case report. (PubMed, Front Oncol) - "Despite initial responses to first-line firmonertinib-based combination therapy, progression-free survival (PFS) 13 months, the patient developed sequential resistance to subsequent regimens, including liver/brain metastases and treatment-related toxicities. After fourth-line therapy failure and severe intolerance to albumin-bound paclitaxel and bevacizumab, two cycles of ivonescimab-a first-in-class programmed cell death protein receptor-1 (PD-1)/vascular endothelial growth factor-A (VEGF-A) bispecific antibody-induced significant regression of pulmonary target lesions (PR), sustained over six cycles with minimal toxicity...While the rapid PR and favorable safety profile are promising, longer follow-up is required to assess durability and survival benefits. These findings underscore the need for further investigation of bispecific antibodies in precision oncology paradigms for multi-refractory EGFR-driven NSCLC."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-1 • PD-L1 • TP53

NOTABLE-309: Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

TOURMALINE study of durvalumab (D) in combination with gemcitabine (G)-based chemotherapy in advanced biliary tract cancer (aBTC): early safety and efficacy results in participants (pts) from Asia (ESMO Asia 2025) - P3 | "We report early safety and efficacy data within a subgroup of pts from Asia. Pts receive D 1500 mg (first infusion: 60 min; subsequent infusions: 30 min) with an investigator-selected G-based chemotherapy (D + G alone or in combination with oxaliplatin [O], carboplatin [C], cisplatin [cis], tegafur-gimeracil-oteracil [S-1], cis + S-1, or cis + nab-paclitaxel [P]). In pts from Asia, the safety profiles of all study tx were manageable. Safety results for pts from Asia were comparable to the global TOURMALINE population and TOPAZ-1 study. Interim ORR is promising."

Clinical • Combination therapy • Metastases • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Neoadjuvant chemo-immunotherapy with camrelizumab plus chemotherapy in resectable or potentially resectable locally advanced head and neck squamous cell carcinoma: an open-label, single-arm, phase II trial (ESMO Asia 2025) - P2 | "Enrolled patients received camrelizumab (200 mg, iv, q3w) in combination with albumin-paclitaxel (260 mg/m2, iv, q3w) and platinum (cisplatin 75 mg/m2 or carboplatin AUC 5, iv, q3w) for 2 cycles. Neoadjuvant chemotherapy plus camrelizumab for locally advanced HNSCC showed potential efficacy and an acceptable safety profile. This encouraging result promotes us to continue this phase Ⅱ study."

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

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

Prognostic impact of thyroid transcription factor-1 (TTF-1) expression and the efficacy of carboplatin plus (nab-) paclitaxel in nonsmall-cell lung cancer complicated with idiopathic interstitial pneumonia (ESMO Asia 2025) - "TTF-1 expression is an independent prognostic factor in patients with NSCLC complicated by IP receiving carboplatin plus (nab-) paclitaxel. TTF-1 expression may serve as a crucial biomarker in characterizing the disease subtypes and guiding therapeutic strategies in lung cancer with coexisting IP."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NKX2-1 • TTF1

Phase II study of atezolizumab plus chemotherapy in patients with advanced nonsquamous non-small-cell lung cancer and poor performance status (ESMO Asia 2025) - "Pts received atezolizumab (1200 mg/body, day 1), carboplatin (AUC 5, day 1), and nab-paclitaxel (75 mg/m2, days 1 and 8) every three weeks for up to four cycles, followed by maintenance atezolizumab (1200 mg/body, day 1) every three weeks until disease progression or unacceptable toxicity. Atezolizumab plus chemotherapy is a promising treatment option for pts with advanced nonsquamous NSCLC and an ECOG PS of 2."

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

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

TitAN: A prospective, single-arm, phase II study of tislelizumab combined with anlotinib and nab-paclitaxel as neoadjuvant therapy for resectable stage III non-small cell lung cancer (ESMO Asia 2025) - P2 | "Primary endpoint: pathological complete response (pCR) rate. Secondary endpoints: major pathologic response (MPR), R0 resection rate, event-free survival (EFS), overall survival (OS), and safety (CTCAE v5.0)."

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

A prospective phase II study of stratified treatment of initially resectable locally advanced head and neck squamous carcinoma (LA HNSCC) based on pathological response after neoadjuvant chemoimmunotherapy (ESMO Asia 2025) - "All patients received albumin-bound paclitaxel 260mg/m2, cisplatin 75mg/m2, and tislelizumab 200 mg on day 1 of every 3-week cycle for 2-3 cycles...Patients who did not achieve MPR received standard IMRT, 60-66 Gy (2.0 Gy/f), 5 times per week for 6-6.5 weeks with concurrent nimotuzumab 200 mg, every week for 7 cycles), and sequential tislelizumab. The primary endpoint was the event-free survival (EFS) rate in 2 years. Secondary endpoints were the objective response rate and pCR rate."

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A clinical parameter-based model predicts survival and response to immuno-chemotherapy in recurrent/metastatic head and neck squamous cell carcinoma (ESMO Asia 2025) - P2 | "This prospective study aims to evaluate the role of routinely measured clinical parameters in predicting treatment efficacy and survival. In this prospective phase 2 study (NCT04857164), 148 patients with R/M HNSCC received first-line pembrolizumab plus nab-paclitaxel and platinum. This study establishes therapeutic stratification using routine clinically accessible parameters to predict immuno-chemotherapy efficacy and outcomes in R/M HNSCC, offering a cost-effective alternative to complex molecular profiling."

Clinical • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pembrolizumab combined with nab-paclitaxel and platinum as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma: A phase II study (ESMO Asia 2025) - P2 | "This phase 2 study aimed to evaluate the efficacy of this triplet regimen in R/M HNSCC patients. In this single-arm phase 2 trial (NCT04857164), 148 treatment-naïve R/M HNSCC patients (any PD-L1 status) received pembrolizumab 200 mg, nab-paclitaxel 260 mg/m2, and cisplatin 75 mg/m2 (or carboplatin AUC5 if contraindicated) Q3W for 6 cycles, followed by pembrolizumab maintenance (up to 35 cycles)... The combination of pembrolizumab, nab-paclitaxel, and platinum demonstrated encouraging efficacy and a manageable safety profile in R/M HNSCC. The favorable efficacy supports further evaluation of this regimen."

Clinical • IO biomarker • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Efficacy and safety of weekly nab-paclitaxel combined with PD-1 inhibitors as second-line therapy in patients with metastatic urothelial carcinoma who failed in platinum-based first-line chemotherapy: A two-center exploratory study (YHCG-004 Study) (ESMO Asia 2025) - "This study suggests that weekly nab-paclitaxel combined with PD-1 Inhibitors as second-line therapy in mUC patients provides encouraging efficacy and a manageable safety profile, and this treatment strategy may be suitable for mUC patients who were failed in platinum-based chemotherapy and are unwilling to receive ADCs based treatment."

Clinical • Metastases • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer

Neoadjuvant Adebrelimab plus SOX and Nab-paclitaxel in Resectable locally advanced gastric and gastroesophageal junction adenocarcinoma: A multicentre, single-arm, prospective phase II trial (ESMO Asia 2025) - P2, P3 | "Background: Perioperative chemotherapy containing fluorouracil, oxaliplatin, and docetaxel is preferred for patients with gastric and gastroesophageal junction adenocarcinoma. The KEYNOTE-585 study reported that the neoadjuvant and adjuvant pembrolizumab plus cisplatin-based chemotherapy group achieved a higher pathological complete response rate than the placebo plus cisplatin-based chemotherapy group...The primary endpoint is the pathological complete response rate. Secondary research endpoints include: major pathologic response, objective response rate, R0 resection rate, disease-free survival, overall survival, and safety."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

YOUNG-NEOS: Phase II study of neoadjuvant nab-paclitaxel, oxaliplatin s-1, and sintilimab for resectable early-onset GC/GEJC patients (ESMO Asia 2025) - P2 | "For perioperative backbone chemotherapy in resectable gastric cancer, Japanese and Chinese guidelines recommend a doublet regimen of fluoropyrimidines plus oxaliplatin, while Western guidelines favor a triplet regimen that adds docetaxel...The study is powered at 80% to detect an increase in pCR rate from 6% to 20% with significance level of 0.05. The first patient will be recruited on September 2025, with full accrual expected by September 2027."

Clinical • P2 data • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • HER-2

Physician choice multi-agent chemotherapy versus gemcitabine monotherapy for advanced pancreatic adenocarcinomas in frail or elderly patients - A randomized phase III clinical trial (ESMO Asia 2025) - "Background: Pancreatic ductal adenocarcinomas (PDAC) frequently present in an advanced unresectable stage (80-85%).Patients with ECOG PS 2 as well as elderly frail patients are underrepresented in trials evaluating advanced PDAC or patients who are not fit for intensive protocols like FOLFIRINOX...we wish to evaluate the benefit of giving a two-drug regimen in these patients versus administering only gemcitabine.Trial design: Phase III, Randomized, Open-label, parallel design, superiority study Histologically confirmed unresectable or metastatic adenocarcinoma of the pancreas or ampulla, with an ECOG PS 2 and age >/= 18 years OR Age >=70 with G8 screening score < 14 and intermediate/high risk on CARG score and adequate haematological, hepatic and renal function are randomized into one of two arms - Arm A (Physician choice multiagent chemotherapy) The treatment regimens allowed are 1.Gemcitabine 1000 mg/m2 IV plus Nab-paclitaxel 125 mg/m2 IV D1, D 8 and D15 q 28..."

Clinical • Metastases • Monotherapy • P3 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Phase II study of adebrelimab combined with apatinib and nab-paclitaxel as second-line therapy in patients with advanced gastric cancer previously treated with immunotherapy (ESMO Asia 2025) - P2 | "The combination of Adebrelimab, Apatinib, and nab-Paclitaxel demonstrated modest efficacy and manageable safety as second-line treatment of advanced gastric cancer, representing a potential new option. Further randomized controlled trials are warranted to confirm the long-term efficacy and safety of this regimen."

Clinical • Metastases • P2 data • Gastric Cancer • Oncology • Solid Tumor

Real-world effectiveness of chemotherapy regimens in advanced pancreatic cancer: A nationwide, population-based cohort study in Taiwan (ESMO Asia 2025) - "Individuals receiving systemic chemotherapy within 90 days of diagnosis were categorized into treatment groups based on initial regimens: gemcitabine alone, gemcitabine plus nab-paclitaxel, S-1 alone, S-1 plus gemcitabine, FOLFIRINOX, GSL (gemcitabine plus S-1 plus leucovorin), 5-FU–based (5-FU with or without leucovorin), or other... This real-world study highlights the comparative effectiveness of chemotherapy regimens in APC and supports gemcitabine-based combinations as important options in East Asian clinical practice."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Real-world evidence on KRAS mutation status in the Japanese population with pancreatic ductal adenocarcinoma (ESMO Asia 2025) - "Inclusion criteria were (1) KRAS-WT or a solitary KRAS-mutated (MT) cases (2) patients who received either gemcitabine plus nab-paclitaxel (GnP) or fluorouracil, folinic acid, irinotecan, and oxaliplatin (FOLFIRINOX) as first-line therapy. KRAS mutation status alone may not predict treatment efficacy in Japanese PDAC patients, but KRAS WT tumors represent a molecularly distinct subset characterized by enriched actionable alterations and immunogenic features."

Clinical • HEOR • Real-world • Real-world evidence • Microsatellite Instability • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • BRAF • BRCA2 • CDKN2A • KRAS • MSI • PIK3CA • SMAD4 • TMB • TP53

NALIRIFOX or AG chemotherapy plus PD-1 blockade sequenced By SBRT as first-line regimen for locally advanced pancreatic cancer (ESMO Asia 2025) - P=N/A | "Eligible pts were randomized 1:1 to experimental arm (PRNFX, Liposomal Irinotecan 50mg/m2 d1,15 + Oxaliplatin 60mg/m2 d1,15 + Leucovorin 200mg/m2 d1,15 + 5-fluorouracil 2400mg/m2 d1,15 + Toripalimab 160mg d1,15 q28d) or controlled arm (PRAG, Gemcitabine 1000mg/m2 d1,8 + nab-paclitaxel 125mg/m2 d1,8 + Toripalimab 240mg d1 q21d). Compared to the Gemcitabine-based counterpart, NALIRIFOX combined with PD-1 inhibitor followed by sequential SBRT+SIB demonstrated a potential efficacy advantage and tolerable safety for LAPC treatment."

Clinical • Metastases • Oncology • Pancreatic Cancer • Solid Tumor

Comparison of S-1 with concurrent radiotherapy or gemcitabine plus nab-paclitaxel combination therapy in patients with locally advanced pancreatic cancer: An integrated analysis of two phase II trials (JCOG2408A) (ESMO Asia 2025) - "JCOG1407 was conducted to evaluate the efficacy and safety of GnP and modified FOLFIRINOX... S-1+RT and GnP, whereas OS and DMFS tended to be longer with GnP. Considering that subsequent treatment was less intensive in S-1+RT group, its OS may have been underestimated, suggesting that S-1+RT remains a potential option for patients with LAPC."

Clinical • Combination therapy • Metastases • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: Results from phase II part of a randomized, open-label, active-controlled, phase II/III study (ESMO Asia 2025) - P2/3 | "S+C+AG regimen significantly improved median PFS versus AG alone, with consistent benefits across key efficacy endpoints. The safety profile is manageable. The tetrad regimen may emerge as a new frontline option for the targeted population."

Clinical • Combination therapy • Metastases • P2/3 data • Oncology • Pancreatic Cancer • Solid Tumor • FGFR

Reduced-intensity CRT plus PD-1 inhibitor for elderly ESCC: A retrospective cohort (ESMO Asia 2025) - P | "We tested a triple-optimised regimen—non-platinum monotherapy, 50.4 Gy radiotherapy and concurrent PD-1 inhibitor—to preserve efficacy and improve safety. This retrospective study enrolled consecutive patients aged ≥70 years with histologically confirmed ESCC (stage II–IV, ECOG PS 0–2) who were registered at the Cancer Center, Chongqing University Three Gorges Hospital, between January 2022 and July 2023, and were followed until August 2025.Treatment comprised 50.4 Gy/28 fractions delivered over 5.5 weeks, concurrent single-agent chemotherapy (S-1 or weekly nab-paclitaxel) and a PD-1 inhibitor (tislelizumab n=18, camrelizumab n=10, sintilimab n=6) for six cycles, followed by PD-1 inhibitor maintenance until progression or intolerance. Moderate-dose radiotherapy combined with single-agent chemotherapy and PD-1 inhibitor is active and well tolerated in elderly ESCC, including PD-L1-negative subgroups. These real-world data support prospective validation."

IO biomarker • Retrospective data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • PD-L1

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients (clinicaltrials.gov) - P1/2 | N=183 | Recruiting | Sponsor: Tango Therapeutics, Inc. | N=133 ➔ 183

Enrollment change • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thoracic Cancer