Avastin (bevacizumab) / Roche - LARVOL DELTA

EMERALD-1: A phase 3, randomized, placebo-controlled study of transarterial chemoembolization combined with durvalumab with or without bevacizumab in participants with unresectable hepatocellular carcinoma eligible for embolization. (ASCO-GI 2024) - P3 | "D+B+TACE is the first ICI-based regimen in a global Phase 3 trial to show statistically significant and clinically meaningful improvement in PFS, vs TACE, in pts with embolization-eligible uHCC. Safety was manageable and consistent with the safety profiles of D, B, and TACE in uHCC. D+B+TACE has the potential to set a new standard of care in uHCC."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer. (ASCO 2025) - P1 | "IBI363 monotherapy demonstrated prolonged overall survival in pts with advanced CRC compared to historic data of standard of care. IBI363 plus beva showed even more encouraging efficacy with acceptable safety and warrants further development."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • Colorectal Cancer • Endocrine Disorders • Microsatellite Instability • Musculoskeletal Pain • Oncology • Solid Tumor • KRAS • MSI • NRAS

Encorafenib, Cetuximab, and mFOLFOX6 in BRAF-Mutated Colorectal Cancer. (PubMed, N Engl J Med) - P3 | "This trial showed significantly longer progression-free survival and overall survival with first-line treatment with EC+mFOLFOX6 than with standard care among patients with BRAF V600E-mutated metastatic colorectal cancer. (Funded by Pfizer and others; BREAKWATER ClinicalTrials.gov number, NCT04607421.)."

Journal • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Efficacy and Safety of Avutometinib ± Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201. (PubMed, J Clin Oncol) - P3 | "The efficacy and safety profile of avutometinib in combination with defactinib support this combination as a potential standard of care for recurrent LGSOC. A randomized phase 3 study of avutometinib and defactinib versus investigator's choice of therapy for women with recurrent LGSOC is currently enrolling (RAMP301; ClinicalTrials.gov identifier: NCT06072781)."

Journal • Fibrosarcoma • Hematological Disorders • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Sarcoma • Solid Tumor • KRAS

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

A phase II study of intrapatient dose escalation of biweekly trifluridine/tipiracil plus bevacizumab for colorectal cancer (E-BiTS study). (PubMed, ESMO Open) - "Intrapatient dose escalation of biweekly FTD/TPI plus BEV was feasible and well tolerated and may enhance the efficacy of refractory mCRC treatment. Nonetheless, further studies are warranted to validate this individualized dosing strategy."

Journal • P2 data • Colorectal Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • RAS

Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naïve Non-Squamous NSCLC with Brain Metastases (SUPER BRAIN) (IASLC-WCLC 2025) - P2/3 | "Patients received serplulimab combined with bevacizumab, pemetrexed, and carboplatin for four to six cycles, followed by maintenance therapy with serplulimab plus bevacizumab and pemetrexed until disease progression, unacceptable toxicity, or death, for up to two years. No treatment-related deaths were reported. Conclusions : Serplulimab plus bevacizumab and chemotherapy demonstrated promising intracerebral antitumor efficacy and a manageable safety profile for patients with non-squamous NSCLC with BMs in the first-line setting."

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

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

IMbrave152/SKYSCRAPER-14: A phase III study of first-line tiragolumab (tira) + atezolizumab (atezo) + bevacizumab (bev) vs placebo (pbo) + atezo + bev for patients (pts) with untreated locally advanced or metastatic hepatocellular carcinoma (HCC) (ESMO 2025) - P3 | "OS data are not expected to reach statistical significance. The study has been unblinded and long-term survival follow-up is ongoing."

Clinical • Late-breaking abstract • Metastases • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • TIGIT

IKF-035/ABC-HCC: A phase IIIb, randomized, multicenter, open-label trial of atezolizumab plus bevacizumab versus transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma (ESMO 2025) - P3 | "The IMbrave150 phase 3 study showed that the combination of the anti-PD-L1 antibody atezolizumab and the anti-VEGF antibody bevacizumab (atezo/bev) extend survival compared to sorafenib in 1L treatment of advanced and intermediate HCC failing/unsuited for TACE. Conclusions The first IA provides important insights into the efficacy of atezo/bev vs. TACE in intermediate stage HCC. Based on these findings, the trial is progressing to the 2nd IA at 66% information time (169 events)."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Liver resection versus continued atezolizumab plus bevacizumab (atezo/bev) in locally advanced hepatocellular carcinoma (HCC) after atezo/bev treatment (TALENTop): A multicenter, open-label, randomized phase III trial (ESMO 2025) - P | "Grade ≥ 3 atezo/bev-related adverse events occurred in 27.7% of pts in arm A vs. 21.0% in arm B. Grade ≥ 3 surgical complication rate was 21.7%. Conclusions For locally advanced HCC pts with PR or SD and eligible for resection after initial atezo/bev treatment, liver resection provided statistically significant and clinically meaningful benefits and showed a trend toward OS benefit compared to continued atezo/bev treatment."

Clinical • Metastases • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

DeFianCe trial: A randomized phase II trial of sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus bevacizumab and chemotherapy as second-line therapy in advanced microsatellite stable (MSS) colorectal cancer (CRC) (ESMO 2025) - P2 | "84% received FOLFIRI on study...Conclusions Sirexa in combination with standard of care (SOC) was well tolerated and demonstrated a promising early signal in DKK1-high MSS CRC pts with significant advantage of PFS and OS compared to SOC alone. Further investigation of sirexa in 2L DKK1-high CRC is warranted."

Clinical • Late-breaking abstract • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • BRAF • DKK1

Nivolumab, ipilimumab and bevacizumab together with 2 cycles of induction chemotherapy in patients with non-squamous NSCLC and untreated brain metastases (CA209-7WF/Break B5-BM-NSCLC/AIO-TRK-0220/ass) (ESMO 2025) - P2 | "Pts received nivolumab (360 mg, q3w), ipilimumab (1 mg/kg, q6w) and bevacizumab (400 mg, q3w) concomitantly with 2 cycles of chemotherapy [carboplatin (AUC 5, q3w) plus nab-paclitaxel (100 mg/m 2 , q1w)]. Most common adverse events grade ≥ 3 were pneumonia (6 pts), neutropenia (5 pts), alanine aminotransferase increased (4 pts), acute kidney injury (3 pts), sepsis (3 pts) and infection (3 pts). Conclusions The Break-B5 trial demonstrated promising intracranial activity in active (asymptomatic + symptomatic) BMs of NSCLC along with a manageable safety profile."

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

NAPISTAR 1-01: A phase I dose escalation study of TUB-040, a novel NaPi2b-targeting exatecan antibody-drug conjugate (ADC) in patients with platinum-resistant ovarian (PROC) high grade serous carcinoma (HGSC) (ESMO 2025) - P1/2 | "Pts had a median age of 62 y (range 34-81), ECOG PS 0 or 1, a median of 4 prior lines of therapy (range 1-7); prior treatment included bevacizumab (84%), PARP inhibitors (76%) and mirvetuximab soravtansine (13%). 1 Values reported with 95% CI. Conclusions TUB-040 was well tolerated with robust clinical activity even at low doses, offering a differentiated potential new option for treatment with a highly favorable benefit–risk profile."

Clinical • Late-breaking abstract • P1 data • Platinum resistant • Lung Cancer • Non Small Cell Lung Cancer • Oncology • MUC16 • SLC34A2

FIRST/ENGOT-OV44 trial: Does the addition of dostarlimab (dost) impact niraparib (nira) tolerability, exposure, or dose modification? (ESMO 2025) - P3 | "The FIRST/ENGOT-OV44 trial (NCT03602859) investigated the addition of dost to 1L platinum-based chemotherapy (PBCT) and nira MT ± bevacizumab (bev). a Among pts who received nira MT. b Thrombocytopenia and anemia include selected preferred terms in the same medical concept, mapped through standardized MedDRA queries."

Oncology • Ovarian Cancer • Solid Tumor

Circulating tumour (ct) DNA analysis of BRAF V600E dynamics and changes in genomic landscape in patients (pts) with first-line (1L) BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated in BREAKWATER (ESMO 2025) - P3 | "Background The randomized phase III BREAKWATER study (NCT04607421) demonstrated statistically significant and clinically meaningful improvements in ORR with encorafenib + cetuximab (EC) + mFOLFOX6 vs chemotherapy ± bevacizumab (control) in 1L BRAF V600E-mutant mCRC (Kopetz et al 2025)...Table: 729MO BRAF V600E VAF-high at BL BRAF V600E VAF-low at BL EC (n=61) EC + mFOLFOX6 (n=95) Control (n=91) EC (n=62) EC + mFOLFOX6 (n=96) Control (n=89) ORR, % (95% CI) 49 (36, 62) 75 (65, 83) 42 (32, 53) 40 (28, 54) 63 (52, 72) 40 (30, 51) OS HR (95% CI) 0.76 (0.52, 1.13) 0.50 (0.35, 0.73) – 0.66 (0.41, 1.06) 0.39 (0.24, 0.64) – ORR, objective response rate; OS, overall survival. Conclusions Clinical benefit across BRAF V600E subgroups and differential patterns of acquired resistance mutations support EC+mFOLFOX6 as a SOC for pts with BRAF V600E-mutant mCRC."

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS • MAP2K1 • NRAS

Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator's choice chemotherapy (ICC): Phase III MIRASOL trial (ESMO 2025) - P3 | "In the ITT, 152/227 (67%) MIRV pts vs 147/226 (65%) ICC pts went on to receive a new anticancer therapy, including, most commonly, taxanes (35% vs 26%), gemcitabine (24% vs 26%), platinum-based compounds (19% each), bevacizumab (19% vs 16%), and anthracyclines (25% vs 9%); 2 (<1%) vs 16 (7%) pts received MIRV. Conclusions MIRV demonstrated favorable PFS2 vs ICC irrespective of prior PARPi or bevacizumab exposure. These results further strengthen MIRV as the standard of care with durable clinical benefit continuing beyond progression."

Clinical • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Leveraging artificial intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: Translational analyses of AtezoTRIBE and AVETRIC trials (ESMO 2025) - P2 | "Methods Lunit SCOPE IO quantified the density of lymphocytes (LC), fibroblasts (FB), macrophages (MP), tumor (TC), endothelial (EC) and mitotic (MTC) cells in cancer area (CA) and stroma (CS) on pre-treatment H&E WSIs from pts with pMMR mCRC enrolled in AtezoTRIBE (FOLFOXIRI/bevacizumab +/- atezolizumab [atezo]) and AVETRIC (FOLFOXIRI/cetuximab/avelumab) trials...In the AVETRIC cohort, WSIs from 48 pts were analyzed; 36 (75%) cases were classified as biomarker- high , with better PFS ( P = .043) and OS ( P = .053) compared to biomarker- low ones. Conclusions Our AI-derived tumour microenvironment biomarker may help to predict benefit from ICI-based treatments in pMMR mCRC, supporting further investigations of AI-powered approaches."

Checkpoint inhibition • Clinical • IO biomarker • Colorectal Cancer • Oncology

Colorectal Cancer Metastatic dMMR Immunotherapy (COMMIT) study: A randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/atezo (FFX/bev) in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC)— NRG-GI004/SWOG-S1610. (ASCO-GI 2026) - P3 | "Background: Immunotherapy for frontline dMMR/MSI-H mCRC is highly effective, however, nearly half of pts treated with pembrolizumab monotherapy in the KEYNOTE 177 trial progressed within 12 months... The combination of FFX/bev+atezo led to significantly longer PFS than atezo monotherapy in the first-line setting for dMMR mCRC. *Drs. Rocha Lima and Overman contributed equally."

Clinical • dMMR • IO biomarker • Metastases • Mismatch repair • Monotherapy • MSI-H • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

A phase 1/2, randomized, global trial to investigate efficacy and safety of EpCAM × 4-1BB bsAb (BNT314/GEN1059) in combination with pumitamig (BNT327; PD-L1 × VEGF-A bsAb) and chemotherapy in patients with metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P1/2 | "In Part C (Phase 2), 2L pts are randomized 1:1:1 to receive BNT314 (Q6W) + BNT327 (Q2W) + SoC chemo, bevacizumab (Q2W) + SoC chemo or BNT327 (Q2W) + SoC chemo. Primary endpoints are safety (Part A & B), objective response rate (ORR) (Part B) and progression free survival (Part C) with key secondary endpoint being ORR in Part C. Overall survival is an exploratory endpoint (Parts A & B) and a secondary endpoint in Part C. The trial was initiated in Q3 2025; recruitment is ongoing in the US. Sites are planned in Europe, Asia-Pacific, and Australia."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • PD-L1 • TNFRSF9

BREAKWATER: Primary analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P3 | "Background: Leucovorin/5-FU in combination with oxaliplatin (FOLFOX) or irinotecan (FOLFIRI) are common chemotherapies used in 1L mCRC. In patients (pts) with BRAF V600E-mutant mCRC, the Phase 3 portion of BREAKWATER (NCT04607421) demonstrated clinically meaningful and statistically significantly improved ORR by blinded independent central review (BICR), PFS by BICR, and OS with 1L EC + mFOLFOX6 vs chemotherapy ± bevacizumab (bev) (Kopetz Nat Med 2025; Elez N Engl J Med 2025)... BREAKWATER Cohort 3 demonstrated a clinically meaningful and statistically significant improved response rate that was rapid and durable with EC+FOLFIRI vs control in 1L BRAF V600E-mutant mCRC, with manageable toxicities and no new safety signals. These data support EC+FOLFIRI as a potential new standard of care in BRAF V600E-mutant mCRC. aBy BICR."

Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

IKF-035/ABC-HCC: A phase IIIb, randomized, multicenter, open-label trial of atezolizumab plus bevacizumab versus transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma. (ASCO-GI 2026) - "The IMbrave150 phase 3 study demonstrated that combination of the anti-PD-L1 antibody atezolizumab and the anti-VEGF antibody bevacizumab (atezo/bev) extends survival compared to sorafenib in first-line treatment of advanced and intermediate stage HCC failing/unsuited for TACE which has led to its approval in this setting. The results of the first IA provide important insights into the efficacy of atezo/bev vs. TACE in intermediate stage HCC and suggest a superiority of systemic therapy compared to TACE in regard to TTFS. Based on these findings, the trial is progressing to the second IA at 66% information time (169 events)."

Clinical • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A phase 1b/2 study on the efficacy and safety of BXQ-350, a first-in-class sphingolipid metabolism modulator, in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma. (ASCO-GI 2026) - P1, P1/2 | "Research Funding Bexion Pharmaceuticals. Primary endpoints are Cumulative Oxaliplatin Dose, ORR and Safety. Secondary endpoints are OS, PFS, DCR, CIPN, PK/PD and biomarkers."

Clinical • Combination therapy • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

BREAKWATER phase 3: Post hoc subgroup analyses by age in patients (pts) with BRAF V600E-mutant metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P3 | "BREAKWATER (Phase 3; NCT04607421) demonstrated statistically significant and clinically meaningful improvements in ORR, PFS by blinded independent central review (BICR), and OS with encorafenib + cetuximab (EC)+mFOLFOX6 vs control (chemotherapy±bevacizumab) in 1L BRAF V600E-mutant mCRC, making EC+mFOLFOX6 a new standard of care... All pts with BRAF V600E-mutant mCRC receiving 1L EC+mFOLFOX6, including EOCRC pts, showed improved ORR, PFS, and OS vs control. The safety profile of EC+mFOLFOX6 was similar for both age groups. NE, not estimable."

Clinical • Metastases • P3 data • Retrospective data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

Phase I trial of high-dose SBRT combined with atezolizumab and bevacizumab in advanced hepatocellular carcinoma. (ASCO-GI 2026) - P1 | "High-dose SBRT combined with atezolizumab/bevacizumab in advanced HCC was feasible, safe, and yielded durable CRs in ~40% of patients. Median DFS and OS exceeded historical benchmarks. These results suggest that SBRT, when combined with atezolizumab and bevacizumab, may stimulate systemic immune activation and reinvigorate both CD8⁺ and CD4⁺ T-cell compartments in patients who experience prolonged clinical benefit."

IO biomarker • Metastases • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD4 • CD8 • PD-1