paclitaxel / Generic mfg. - LARVOL DELTA

Overall survival and progression-free survival by PD-L1 status among endometrial cancer patients treated with pembrolizumab plus carboplatin/paclitaxel as compared to carboplatin/paclitaxel plus placebo in the NRG GY018 trial (SGO 2024) - "Immature OS analysis (IA1) suggested a directionally favorable benefit with the addition of pembrolizumab to CP in both the dMMR and pMMR EC cohorts despite (%***pending) crossover to immunotherapy at progression.  Incorporation of Pembrolizumab resulted in a significant improvement in PFS irrespective of PD-L1 expression levels."

Clinical • IO biomarker • Late-breaking abstract • Endometrial Cancer • Oncology • Solid Tumor • PD-L1

NRG-BR003: A randomized phase III trial comparing doxorubicin plus cyclophosphamide followed by weekly paclitaxel with or without carboplatin for node-positive or high-risk node-negative TNBC. (ASCO 2025) - P3 | "The addition of carbo to P following DD AC for adjuvant therapy of node-positive or high-risk node-negative TNBC did not result in a statistically significant improvement in IDFS, DRFI, or OS. However, it increased grade ≥3 treatment-related AE rates. Although not meeting criteria for efficacy across the entire study population, results support planned translational research to identify subsets of pts who may benefit from carbo."

Clinical • Late-breaking abstract • P3 data • Triple Negative Breast Cancer • BRCA

Atezolizumab plus bevacizumab and chemotherapy in metastatic nonsquamous NSCLC: the randomized double-blind phase 3 IMpower151 trial. (PubMed, Nat Med) - P3 | "Chemotherapy-naive patients with metastatic nsqNSCLC (N = 305) were randomized 1:1 to receive either atezolizumab, bevacizumab, carboplatin and paclitaxel or pemetrexed (ABCPem/Pac; n = 152) or placebo plus bevacizumab, carboplatin and pemetrexed or paclitaxel (BCPem/Pac; n = 153). ABCPem/Pac was generally well tolerated, with no new safety signals. Trial registration number: ClinicalTrials.gov, NCT02366143."

Journal • P3 data • Endocrine Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial. (PubMed, Lancet) - P1/2 | "This is the first randomised controlled trial of CAR T-cell therapy in solid tumours globally. Satri-cel treatment resulted in a significant improvement in progression-free survival, with a manageable safety profile. These results support satri-cel as a new third-line treatment for advanced gastric or gastro-oesophageal junction cancer patients."

Journal • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Trastuzumab Deruxtecan or Ramucirumab plus Paclitaxel in Gastric Cancer. (PubMed, N Engl J Med) - P3 | "Trastuzumab deruxtecan led to significantly longer overall survival than ramucirumab plus paclitaxel among patients with HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Adverse events were common in both groups. Events of interstitial lung disease or pneumonitis with trastuzumab deruxtecan, a known risk, were mainly low-grade. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Gastric04 ClinicalTrials.gov number, NCT04704934.)."

Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Interstitial Lung Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. (PubMed, Lancet) - P3 | "Retifanlimab provides clinical benefit, with a manageable safety profile, when added to first-line chemotherapy in advanced squamous cell carcinoma of the anal canal. These results suggest retifanlimab with carboplatin plus paclitaxel should be considered as the new standard of care for patients with advanced squamous cell anal carcinoma."

Clinical • Journal • P3 data • Anal Carcinoma • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • CD4 • PD-L1

Digital Versus Manual PD-L1 Scoring in Advanced Non-Small Cell Lung Cancer From the IMpower110 and IMpower150 Trials. (PubMed, J Thorac Oncol) - "AIM-PD-L1 digital SP263 PD-L1 scoring is concordant with manual scoring showing similar predictivity for benefit and could potentially be used as a predictive marker for patient stratification and selection for anti-PD-(L)1 therapy."

IO biomarker • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

First-Line Atezolizumab Plus Chemotherapy in Elderly Patients With Advanced NSCLC, IFCT-1805 Elderly: A Randomized, Multicenter, Phase 3 Trial (IASLC-WCLC 2025) - "The IFCT-1805 ELDERLY trial assessed the addition of atezolizumab (ATZ), an ICI targeting the human programmed death-ligand 1 (PD-L1), to the current standard of care by monthly carboplatin with weekly paclitaxel CT (E Quoix et al, Lancet 2011) in elderly patients with advanced NSCLC. Conclusions : In the IFCT-1805 ELDERLY trial, despite a numerically longer OS when adding ATZ to the current standard of care CT for first line therapy of elderly patients with NSCLC, the gain was not statistically significant. However, the addition of ATZ to CT significantly improved the PFS, the ORR and the DOR regardless of PD-L1 expression."

Clinical • IO biomarker • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR

Phase III study of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (HARMONi-6) (ESMO 2025) - P3 | "Background Ivonescimab significantly improved PFS over pembrolizumab as first-line therapy for advanced NSCLC in PD-L1 TPS ≥1%...Methods Eligible patients with untreated stage IIIB-IV squamous NSCLC were randomized (1:1) to ivonescimab 20 mg/kg Q3W or tislelizumab 200 mg Q3W, plus paclitaxel (175 mg/m2) and carboplatin (AUC 5) for 4 cycles, followed by ivonescimab or tislelizumab monotherapy as maintenance treatment...Safety analyses revealed treatment-related SAE in 32.3% vs. 30.2%, and grade≥3 hemorrhagic events occurred in 1.9% vs. 0.8%, for ivonescimab and tislelizumab groups, respectively. Conclusions This phase III trial result suggests first-line ivonescimab-chemotherapy may be a new standard of care for advanced/metastatic squamous NSCLC."

Clinical • IO biomarker • IO biomarker • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DESTINY-Breast11: Neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC) (ESMO 2025) - P3 | "We report neoadjuvant T-DXd or T-DXd-THP vs dose-dense doxorubicin + cyclophosphamide (ddAC)-THP in a phase 3, multicenter, open-label, randomized study. Table: 291O T-DXd-THP ddAC-THP Full analysis set, n 321 320 pCR rate, %* 67.3 56.3 ΔpCR vs ddAC-THP, % (95% CI; P value) † 11.2 (4.0, 18.3; 0.003) − EFS hazard ratio (95% CI) ‡ 0.56 (0.26, 1.17) − Safety analysis set, n 320 312 Any SAE, n (%) 34 (10.6) 63 (20.2) Any AE leading to, n (%) Dose reduction 58 (18.1) 60 (19.2) Dose interruption 121 (37.8) 170 (54.5) Drug discontinuation 45 (14.1) 31 (9.9) Death 2 (0.6) 2 (0.6) Drug-related adjudicated ILD / pneumonitis, n (%) 14 (4.4) 16 (5.1) Grade ≥3 2 (0.6) 6 (1.9) 5 1 (0.3) 1 (0.3) Left ventricular dysfunction, n (%) 6 (1.9) 28 (9.0) Grade ≥3 1 (0.3) 7 (2.2) *By blinded central review † Stratified Miettinen & Nurminen method; P value crossed the 0.03 prespecified boundary ‡ 4.5% maturity Conclusions Neoadjuvant T-DXd-THP demonstrated a clinically meaningful and..."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase III ENGOT-ov65/KEYNOTE-B96 study (ESMO 2025) - P3 | "Grade ≥3 treatment-related adverse events occurred in 67.5% versus 55.3% of participants, respectively. Conclusions Pembrolizumab plus weekly paclitaxel ± bevacizumab showed statistically significant and clinically meaningful improvements in PFS regardless of PD-L1 status and in OS in PD-L1 CPS ≥1 PRROC, with a manageable safety profile."

Clinical • Late-breaking abstract • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • PD-L1

KEYMAKER-U01 substudy 01A: Investigational agents + pembrolizumab (pembro) and chemotherapy (chemo) in untreated stage IV non-small cell lung cancer (NSCLC) (ESMO 2025) - P1/2 | "Methods Adults with untreated confirmed stage IV NSCLC, measurable disease per RECIST v1.1, and no EGFR , ALK , or ROS1 mutations received pembro 200 mg + chemo (carboplatin + paclitaxel [squamous] or pemetrexed [nonsquamous]) Q3W with vibostolimab IV 200 mg Q3W, boserolimab IV 30 mg Q6W, MK-4830 IV 800 mg Q3W, or MK-0482 IV 750 mg Q3W for 4 cycles, followed by pembro with the same investigational agent (+ pemetrexed for nonsquamous) for 35 total cycles or until PD or unacceptable toxicity. a Investigator-assessed per RECIST v1.1. Conclusions Pembro and chemo + investigational agents demonstrated antitumor activity similar to previous reports for pembro and chemo and manageable AEs in untreated stage IV squamous or nonsquamous NSCLC."

IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CD27 • EGFR • ROS1 • TIGIT

Low dose pembrolizumab in addition to neoadjuvant anthracycline and taxane in triple-negative breast cancer: A randomized controlled trial (ESMO 2025) - "Patients with untreated stage II-III TNBC without access to standard dose pembrolizumab (SDPm) were randomized (1:1) to receive neoadjuvant dose-dense chemotherapy (4 cycles of doxorubicin and cyclophosphamide followed by 4 cycles of paclitaxel) with or without 50 mg LDPm administered every 6 weeks for 3 cycles. Conclusions The absolute benefit with LDPm appears numerically comparable to that observed with SDPm in the KN522 trial. Therefore, in resource-constrained settings where SDPm is inaccessible, a low-dose alternative strategy may provide a viable treatment option in patients with TNBC."

Clinical • Late-breaking abstract • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Sustainable and efficient platform trial of new therapeutic development for early breast cancer (JCOG2205: S-FACT trial) (ESMO 2025) - P2 | "One TN cohort has already been initiated: Carboplatin plus paclitaxel plus pembrolizumab followed by niraparib plus pembrolizumab. Postoperative follow-up will be conducted as an accompanying observational study to evaluate prognosis, including invasive disease-free survival and overall survival."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial. (PubMed, Lancet) - P3 | "In patients with untreated advanced squamous NSCLC, ivonescimab plus chemotherapy showed significantly improved progression-free survival compared with tislelizumab plus chemotherapy, regardless of PD-L1 status, as well as a manageable safety profile. This regimen could be used as a novel first-line treatment in this patient group."

Journal • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PEMBROLIZUMAB VS PLACEBO PLUS PACLITAXEL ± BEVACIZUMAB FOR PLATINUM-RESISTANT RECURRENT OVARIAN CANCER: RESULTS FROM THE PHASE 3 ENGOTOV65/KEYNOTE-B96 STUDY (IGCS 2025) - P3 | "Efficacy results favored the pembrolizumab arm (Table 1). Subsequent anticancer therapies were used by 52.2% and 60.4% in the pembrolizumab and placebo arms, respectively (Table 2). Grade ≥3 treatment-related adverse events occurred in 67.5% vs 55.3%, respectively."

Clinical • Late-breaking abstract • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • PD-L1

Tumor infiltrating lymphocytes (TILs) and pathologic complete response (pCR) in stage II/III HER2+ breast cancer treated with taxane, trastuzumab, and pertuzumab (THP): secondary results from the ECOG-ACRIN EA1181/CompassHER2 pCR trial (SABCS 2025) - P2 | " EA1181 (NCT04266249) enrolled patients (pts) with anatomic clinical stage II/III HER2+ breast cancer who preoperatively received 4 cycles of trastuzumab and pertuzumab with 12 weeks of paclitaxel or docetaxel q3w x 4 (THP), followed by surgery. sTILs were associated with pCR after THP, further supporting the important role of immune mechanisms in HER2+ breast cancer, and highlighting a potentially robust predictive tool to assess pathologic response. Baseline sTILs could potentially inform the preoperative design of future trials of therapy optimalization. Association of baseline sTILs with recurrence free survival in EA1181 will be reported in the future."

Clinical • Tumor-infiltrating lymphocyte • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer • HER-2

Primary Results from the HR+/HER2- Cohort of TBCRC-053 (P-RAD): A Randomized Trial of No, Low, or High Dose Preoperative RADiation with Pembrolizumab and Chemotherapy in Node-Positive, HER2-Negative Breast Cancer (SABCS 2025) - P2 | "Patients subsequently received pembrolizumab with 12 weeks of paclitaxel, followed by 4 cycles of adriamycin-cyclophosphamide (q2wk or q3wk) with pembrolizumab (200 mg q3 wks or 400 mg q6 wks). The addition of 24Gy preop RT to aPD1 significantly increased tumor TCI in HR+/HER2- early-stage BC. Non-irradiated nodal response rates were promising despite over one-third of the study population with grade 1/2 tumors and high disease burden, laying the foundation for a future randomized trial comparing the efficacy of this novel approach against standard of care for node-positive HR+/HER2- BC."

Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • CD8 • HER-2 • PGR

Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer (CemiHALT) (SABCS 2025) - P2 | "Pts were treated with standard taxane and anthracycline-based NACT (weekly paclitaxel x 12 with carboplatin added for TNBC only, followed by adriamycin and cyclophosphamide x 4 cycles)...The trial was later amended to incorporate cemiplimab concurrently throughout NACT for TNBC pts after FDA approval of neoadjuvant pembrolizumab per KEYNOTE-522 in July 2021... Addition of cemiplimab to NACT resulted in 23% pCR rate in the overall cohort with a significantly higher pCR (50%) seen in TNBC pts. Baseline PD-L1 and/or PD-L2 expression was not associated with pCR rates or radiographic responses. This study incorporated only 2 doses of cemiplimab for ER+ pts which could explain the low pCR rates in this cohort."

IO biomarker • Metastases • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PD-L2

Phase II Study of Low-Dose Paclitaxel and Cisplatin in Combination with Split-Course Concomitant Twice-Daily Reirradiation in Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN): Long-term follow-up of NRG Oncology Radiation Therapy Oncology Group (RTOG) Protocol 9911. (PubMed, Int J Radiat Oncol Biol Phys) - "Despite a high incidence of grade 5 toxicity, OS rates for this trial evaluating concurrent split course BID re-irradiation with cisplatin and paclitaxel exceeded results seen historically with chemotherapy alone."

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

CRITICS-II: A multicenter randomized phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer. (ASCO-GI 2026) - P2 | " In this multicenter phase II study, patients with clinical stage IB-IIIC (TNM8) resectable gastric adenocarcinoma were randomized between: (arm 1) 4 cycles docetaxel+oxaliplatin+capecitabine (DOC), (arm 2) 2 cycles DOC followed by chemoradiotherapy (45Gy/25 fractions + weekly paclitaxel/carboplatin) or (arm 3) chemoradiotherapy. Preoperative chemotherapy alone failed the EFS threshold, showed lowest survival and high toxicity, and was excluded from further evaluation. Both arm 2 and 3 were sufficiently active; survival favored arm 2, toxicity/compliance favored arm 3. Considering postoperative complications and pathological response rates, arm 2 ("total neoadjuvant" chemotherapy + chemoradiotherapy) emerged as the preferred candidate for further study, especially in the context of organ sparing approaches."

Clinical • P2 data • Surgery • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase II trial of systemic therapy plus intraperitoneal (IP) paclitaxel (PTX) in gastric/GEJ cancer peritoneal carcinomatosis (GPC): STOPGAP trial. (ASCO-GI 2026) - "After diagnostic laparoscopy (diag lap), and IP port placement, pts were treated with IP PTX 40 mg/m2 plus IV PTX 50 mg/m2, leucovorin 20 mg/m2 and 5-fluorouracil 400 mg/m2 (bolus) on days1 and 8, every 21 days for 4 cycles. If indicated, anti-PD1 antibody +/- trastuzumab were continued as before enrollment... Iterative normothermic IP PTX plus systemic treatment in GPC is safe and feasible, with encouraging clinical efficacy and safety in historically poor risk patients. The ongoing Phase 2/3 EA2234 STOPGAP II randomized trial will investigate the OS benefit of this approach compared to systemic therapy alone. Median PFS and OS from diagnosis and on study (months (95% CI)."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

Harperoids A-F, Complex Polyprenylated Acylphloroglucinols from Harrisonia perforata that Reverse Multidrug Resistance by Targeting ABC Transporter Function. (PubMed, J Org Chem) - "Interestingly, compound 3 at 20 μM exhibited negligible cytotoxicity but significantly potentiated the activity of paclitaxel against HCT-15 cells by 42.8-fold. Mechanistic studies further demonstrated that compound 3 did not significantly alter the expression levels of ATP-binding cassette (ABC) transporters, but potently inhibited the transport function of both ABCB1 and ABCG2. Molecular docking reveals that compound 3 stably binds to the central substrate-binding cavities of ABCB1 and ABCG2, with its binding primarily stabilized by hydrogen bonds and hydrophobic interactions."

Journal • ABCB1 • ABCG2

AADAT-Driven Metabolic Control of Malate and CoQ 10 Shapes Immune Evasion in Triple-Negative Breast Cancer. (PubMed, bioRxiv) - "In vivo, malate supplementation in drinking water phenocopied AADAT knockdown, restored the response to paclitaxel plus anti-PD-1 therapy in multiple independent syngeneic TNBC models with de novo or acquired resistance to immunotherapy, reduced tumor burden, and prolonged survival...Blocking AADAT or administering oral malate reactivates CD8⁺ T-cell immunity and sensitizes chemo-immunotherapy-resistant tumors to these agents. These findings uncover a readily translatable metabolic vulnerability with potential to improve outcomes for patients with aggressive breast cancer subtypes."

IO biomarker • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • IFNG • TNFA

Accessibility of the unstructured α-tubulin C-terminal tail is controlled by microtubule lattice conformation. (PubMed, Elife) - "Lattice binding of the Y-αCTT probes can be increased by three different ways of changing the tubulin conformational state: the drug Taxol, expression of microtubule-associated proteins (MAPs) that recognize or promote an expanded tubulin conformation, or expression of tubulin that cannot hydrolyze GTP. Molecular dynamics simulations indicate that the Y-αCTT undergoes numerous transient interactions with the bodies of α-tubulin and β-tubulin in the lattice, and that the frequency of these interactions is regulated by the tubulin nucleotide state. These findings suggest that accessibility of the Y-αCTT is locally governed by nucleotide- and MAP-dependent conformational changes to tubulin subunits within the microtubule lattice."

Journal