IMC001 / Immunofoco - LARVOL DELTA

Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145). (ASCO 2025) - P1/2, P3 | "The combination of LUR and ATZ showed promising efficacy in patients with relapsed SCLC regardless of prior exposure to immunotherapy, including those with resistance to platinum. The associated safety profile is manageable. The regimen is being evaluated in a phase III trial in the maintenance setting (IMforte trial NCT05091567)."

Clinical • Metastases • P1/2 data • Febrile Neutropenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study. (ASCO 2025) - P1 | "After lymphodepletion (LD) with fludarabine and cyclophosphamide ± ALLO-647 (anti-CD52), patients received a single infusion of ALLO-316 following a 3+3 design (40-240 × 106 allogeneic CAR+ T cells)... After a median follow-up of 6.8 months, a single infusion of ALLO-316 had manageable safety and encouraging antitumor activity in heavily pretreated patients. Further evaluation of ALLO-316 in CD70 positive ccRCC is warranted. aALLO-316 80 × 106 CAR+ T cells and LD with fludarabine 30 mg/m2 + cyclophosphamide 500 mg/m2."

Metastases • P1 data • Autoimmune Hepatitis • Cardiovascular • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Graft versus Host Disease • Hepatology • Immunology • Infectious Disease • Oncology • Septic Shock • Solid Tumor • CD70

Zanzalintinib (zanza) + nivolumab (nivo) ± relatlimab (rela) in patients (pts) with previously untreated clear cell renal cell carcinoma (ccRCC): Results from an expansion cohort of the phase 1b STELLAR-002 study. (ASCO 2025) - P1 | "First-line zanza had acceptable tolerability in combination with nivo or nivo/rela with a low rate of PPE; zanza+nivo showed promising preliminary activity in pts with adv/met ccRCC."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Dermatology • Genito-urinary Cancer • Hypertension • Oncology • Solid Tumor • AXL

Long-term safety and efficacy of sotorasib plus panitumumab and FOLFIRI for previously treated KRAS G12C-mutated metastatic colorectal cancer (mCRC): CodeBreaK 101 (phase 1b). (ASCO 2025) - P1, P3 | "Discontinuation of sotorasib, panitumumab, or FOLFIRI (5-FU, irinotecan, or leucovorin/levoleucovorin) due to AEs was observed in 1 (2.5%), 1 (2.5%), and 16 (40.0%) patients, respectively... Sotorasib plus panitumumab and FOLFIRI showed promising long-term safety and efficacy in pretreated KRAS G12C-mutated mCRC. AEs were consistent with the safety profile of the drugs administered. The ongoing phase 3 study, CodeBreaK 301 (NCT06252649), aims to evaluate this combination against standard of care in first-line patients with KRAS G12C-mutated mCRC."

Clinical • Metastases • P1 data • Colorectal Cancer • Dental Disorders • Dermatitis • Dermatology • Immunology • Oncology • Solid Tumor • Stomatitis • KRAS

Emiltatug ledadotin (Emi-Le): A B7-H4-directed dolasynthen antibody-drug conjugate (ADC) being investigated in phase 1 dose expansion in patients with triple negative breast cancer who received at least one prior topoisomarase-1 inhibitor ADC. (ASCO 2025) - P1 | "Emiltatug ledadotin (Emi-Le; XMT-1660) is a B7-H4-directed Dolasynthen ADC designed with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin F-HPA microtubule inhibitor payload with controlled bystander effect...The protocol includes the option for multiple additional indications, including HR+/HER2- breast cancer, endometrial cancer, ovarian cancer, and ACC-1. NCT05377996"

Clinical • P1 data • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2 • VTCN1

Initial phase 1 dose escalation data for emiltatug ledadotin (Emi-Le), a novel B7-H4-directed dolasynthen antibody-drug conjugate. (ASCO 2025) - P1 | "Emi-Le (XMT-1660) is a B7-H4-directed Dolasynthen ADC designed with a proprietary auristatin F-HPA microtubule inhibitor payload with controlled bystander effect... Based on the initial reported data, Emi-Le appears to have encouraging clinical activity and tolerability in a heavily pretreated population. Further clinical development is ongoing in the EXP portion of the trial at a dose of 67.4 mg/m2 Q4W in pts with advanced/metastatic TNBC who have received 1-4 prior lines of systemic therapy, including at least one topo-1 ADC. Dose exploration is ongoing to identify a potential second higher EXP dose."

P1 data • Adenoid Cystic Carcinoma • Fatigue • Interstitial Lung Disease • Neutropenia • Oncology • Optic Neuritis • Pain • Pulmonary Disease • Renal Disease • Respiratory Diseases • Thrombocytopenia • Triple Negative Breast Cancer • HER-2 • VTCN1

IMproveMF update: Phase 1/1B trial of imetelstat (IME)+ruxolitinib (RUX) in patients (pts) with intermediate (INT)-1, INT-2, or high-risk (HR) myelofibrosis (MF). (ASCO 2025) - P1, P2 | "In part 1 of IMproveMF, no DLTs were observed and the RP2D dose of 9.4 mg/kg IME was determined. AEs were consistent with those observed in other IME clinical trials, and preliminary efficacy was positive, demonstrating the potential of IME+RUX in this pt population with high unmet needs. Part 2 of this trial is ongoing across the US at 6 sites."

Clinical • P1 data • Anemia • Fatigue • Hematological Disorders • Infectious Disease • Leukopenia • Myelofibrosis • Neutropenia • Pain • Pneumonia • Respiratory Diseases

Efficacy and safety of pralsetinib in patients with advanced RET-fusion-positive NSCLC: Final data from the phase 1/2 ARROW study. (ASCO 2025) - P1/2 | "Pralsetinib produced clinically meaningful and durable responses in patients with RET-fusion-positive NSCLC (regardless of prior therapies) with a manageable safety profile, confirming with this longer follow up previously published results. aPer FDA censoring rule."

Clinical • Metastases • P1/2 data • Anemia • Hypertension • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • RET

Phase 1 study of B440, an oral Bifidobacterium-engineered WT1 cancer vaccine, in patients with metastatic urothelial cancer. (ASCO 2025) - P1 | "B440 exhibited a favorable safety profile and no DLTs up to 1,600 mg. The induction of WT1-specific immunity correlated with improved PFS during B440 therapy and enhanced responses upon pembrolizumab rechallenge. These data support further investigation of B440 in larger, randomized trials and potential combination with other immunotherapies in WT1-expressing malignancies."

Clinical • Metastases • P1 data • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Oncology • Oral Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • Wilms Tumor • IFNG • IL6 • WT1

RETRACTED: Phase 1 clinical trial of EpCAM CAR-T cell therapy in patients with gastrointestinal cancers. (ASCO 2025) - P1 | "EpCAM CAR-T therapy was well tolerated and showed promising efficacy in gastric cancer. Our findings highlight the importance of antigen presentation and activation of natural killer T cells in mediating therapeutic responses, providing valuable insights into optimizing CAR-T cell therapy for solid tumors. Further studies are warranted to refine dosing strategies and identify biomarkers predictive of response to enhance the safety and efficacy of this approach."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EPCAM

Phase 1 clinical update of IMA203, an autologous TCR-T targeting PRAME in patients with PD1 refractory metastatic melanoma. (ASCO 2025) - P1, P3 | "IMA203 TCR-T was well tolerated and showed durable objective responses in patients with advanced melanoma. Given its promising risk/benefit profile and high PRAME prevalence in melanoma, a registration-directed Phase 3 trial (SUPRAME; NCT06743126) is underway to further evaluate its efficacy in patients with previously treated (2L) advanced cutaneous melanoma."

Clinical • Metastases • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Synovial Sarcoma • HLA-A • PD-1 • PRAME

Precemtabart tocentecan (M9140), an anti-CEACAM5 ADC with exatecan payload, in patients with metastatic colorectal cancer (mCRC): Results from the dose optimization of the phase 1 PROCEADE CRC-01 study. (ASCO 2025) - P1, P1/2 | " This global Phase 1 study in 3L adult patients with locally advanced/mCRC (ECOG PS ≤1; previous irinotecan therapy) evaluates clinical activity, safety, and tolerability of precemtabart tocentecan... These preliminary results corroborate the encouraging efficacy and safety data from the dose escalation part of the PROCEADE CRC-01 study, with no new relevant safety findings. ORR was higher at 2.8 mg/kg, with similar tolerability at both doses. The ORR of 24.1% (13.8% confirmed) at 2.8 mg/kg compares favorably with current monotherapy SoCs (ORRs 1-2%) and recent phase 3 data with trifluridine–tipiracil + bevacizumab (ORR 6.1%) in 3L+ mCRC."

Clinical • Metastases • P1 data • Anemia • Colorectal Cancer • Febrile Neutropenia • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CEACAM5

Combination casdatifan plus cabozantinib expansion cohort of phase 1 ARC-20 study in previously treated patients with clear cell renal cell carcinoma. (ASCO 2025) - P1 | "In previously treated patients with ccRCC, casdatifan 100 mg in combination with cabozantinib 60 mg had a manageable AE profile with promising clinical activity. These data support continued evaluation of this combination in the phase 3 PEAK-1 clinical trial."

Clinical • IO biomarker • P1 data • Anemia • Clear Cell Renal Cell Carcinoma • Fatigue • Genito-urinary Cancer • Oncology • Solid Tumor • EPAS1

Clinical activity of EBC-129, a first-in class, anti N256-glycosylated CEACAM5 and CEACAM6 antibody-drug conjugate (ADC), in patients with pancreatic ductal adenocarcinoma (PDAC) in a phase 1 study. (ASCO 2025) - P1 | "EBC-129 shows promising clinical activity in heavily treated PDAC patients with a manageable tolerability profile, consistent with MMAE-based ADCs. Further evaluation of EBC-129 in PDAC, both as monotherapy and in combination with chemotherapy, is planned. (NCT05701527)."

Clinical • P1 data • Anemia • Neutropenia • Oncology • Pain • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CEACAM5 • CEACAM6

First-in-human study of JNJ-79635322 (JNJ-5322), a novel, next-generation trispecific antibody (TsAb), in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial phase 1 results. (ASCO 2025) - P1 | "In the largest data set for a next-generation dual antigen T-cell redirecting TsAb, the first clinical data for JNJ-5322 showed a 100% ORR at the putative RP2D in anti-BCMA/-GPRC5D naïve patients, with convenient Q4W dosing. Tolerability appeared improved, including lower incidence and severity of GPRC5D-associated AEs vs anti-GPRC5D BsAbs and manageable gr 3/4 infection rates. CRS was mostly gr 1 (no gr ≥3 CRS) using 1 SUD."

Clinical • P1 data • Trispecific • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology

DB-1310, a HER3-targeted ADC, in pts with advanced solid tumors: Preliminary results from the phase 1/2a trial. (ASCO 2025) - P1/2 | "DB-1310 showed a manageable safety profile and encouraging antitumor activity in pts with heavily pretreated advanced solid tumors, particularly EGFRm NSCLC. Tumor response by dose (efficacy-evaluable)."

Clinical • Metastases • P1/2 data • Anemia • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • ERBB3

A phase 1/2 open-label, multicenter, first-in-human study of the safety, tolerability, pharmacokinetics, and antitumor activity of BH-30643 in adult subjects with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations (SOLARA). (ASCO 2025) - P1/2 | "Plasma is collected for circulating tumor DNA (ctDNA) analysis at baseline and on treatment. Enrollment is underway, with planned enrollment across ~35 sites in multiple continents."

Clinical • Metastases • P1/2 data • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • ROS1

A phase 1 study of intracerebroventricular (ICV) delivery of bivalent chimeric antigen receptor (CAR) T-cells targeting EGFR and IL13Ra2 in patients with recurrent glioblastoma (rGBM). (ASCO 2025) - P1 | "ICV delivery of CART-EGFR-IL13Rα2 is feasible and appears safe. CART-EGFR-IL13Rα2 cells are bioactive and exhibit an encouraging early efficacy signal in rGBM."

Clinical • P1 data • Brain Cancer • CNS Tumor • Fatigue • Glioblastoma • Oncology • Solid Tumor • CD8 • EGFR • IL13RA2 • MGMT

Phase 1 dose escalation results of the WEE1 inhibitor, azenosertib (A), in combination with encorafenib (E) and cetuximab (C) in patients (pts) with previously treated BRAF V600E mutant metastatic colorectal cancer (mCRC). (ASCO 2025) - P1 | "The combination of A+E+C was well tolerated at the MTD and yielded response rates in BRAFi-naïve mCRC pts which exceeded the historical data from the E+C doublet."

Clinical • Combination therapy • Metastases • P1 data • Atrial Fibrillation • Cardiovascular • Colorectal Cancer • Fatigue • Neutropenia • Oncology • Solid Tumor • BRAF • CYP2C19 • CYP3A4

Phase 1b/2 study evaluating telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with budigalimab in patients (pts) with advanced non-squamous (NSQ) non-small cell lung cancer (NSCLC) with no prior treatment for advanced disease and no actionable genomic alterations. (ASCO 2025) - P1, P1/2 | "Pts are randomized 1:1:1:1 to Temab-A at 1 of 2 doses determined in part 1 + budigalimab, to budigalimab + CT, or to SOC (pembrolizumab + CT) arms...Treatment continues until disease progression, intolerable toxicity, or other discontinuation criteria are met. The first dosing of the first patient enrolled is planned in March 2025."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

Phase 1/2 Duravelo-1 study: Preliminary results of nectin-4–targeting zelenectide pevedotin (BT8009) plus pembrolizumab in previously untreated, cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. (ASCO 2025) - P1/2, P2/3 | "Zelenectide pevedotin (zele, previously BT8009) is a highly selective Bicycle Toxin Conjugate (BTC) targeting Nectin-4 and conjugated to MMAE, and has shown an objective response rate (ORR) of 45% and a generally tolerable safety profile as monotherapy in previously treated, enfortumab vedotin-naïve pts with mUC in the ongoing Phase 1/2 study (NCT04561362, Duravelo-1; Reig et al., 2024)... Zelenectide pevedotin + pembro shows promising anti-tumor activity as a first-line treatment in a cohort of cisplatin-ineligible pts with la/mUC including a large proportion of pts with PS = 2. The combination of zele + pembro was generally tolerable and broadly consistent with the existing safety profiles of each respective agent. No new safety signals were observed with the combination."

Clinical • Metastases • P1/2 data • Diabetes • Genito-urinary Cancer • Infectious Disease • Neutropenia • Oncology • Ophthalmology • Pain • Pneumonia • Respiratory Diseases • Solid Tumor • Urothelial Cancer • NECTIN4

KEYMAKER-U01 substudy 01A: Phase 1/2 study of pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan (HER3-DXd) with or without chemotherapy in untreated stage IV non–small-cell lung cancer. (ASCO 2025) - P1/2 | "KEYMAKER-U01 substudy 01A (NCT04165070) is a phase 1/2, two-part, rolling arm, open-label study assessing the efficacy and safety of pembrolizumab plus an investigational agent (part A: vibostolimab, boserolimab, MK-4830, and MK-0482; part B: I-DXd and HER3-DXd), with or without chemotherapy in untreated stage IV NSCLC...In Arms 5 and 6, participants will receive I-DXd plus pembrolizumab 200 mg Q3W (Arm 5) or I-DXd plus pembrolizumab with 4 cycles of carboplatin area under the curve 5 or 6 mg/ml/min (Arm 6); I-DXd dose will be at 8mg/kg...The primary endpoint is incidence of dose-limiting toxicities until the start of cycle 2, and AEs and treatment discontinuations due to AEs until 40 days after last treatment (90 days for serious AEs); secondary endpoints include ORR and DOR, both per RECIST v1.1 by BICR, and pharmacokinetic parameters, including maximum concentration (Cmax) and maximum trough concentration (Ctrough) of I-DXd and HER3-DXd. Enrollment will be..."

IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ERBB3 • HER-2 • ROS1

Ziftomenib in relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML): Phase 1b/2 clinical activity and safety results from the pivotal KOMET-001 study. (ASCO 2025) - P1/2 | "Median age was 69 yrs (range 22–86), 56% female, 83% ECOG PS 0–1, median of 2 prior therapies (range 1–7), including 60% prior venetoclax (VEN) and 23% prior transplant... In the pivotal KOMET-001, the phase 2 primary endpoint was met: Ziftomenib achieved deep and durable responses in R/R NPM1-m AML, regardless of prior VEN. Ziftomenib was well tolerated with limited myelosuppression and only 3% ziftomenib-related discontinuations. Taken together, these data support the potential use of ziftomenib monotherapy as a new treatment option for R/R NPM1-m AML."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Anemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • Thrombocytopenia • KMT2A • NPM1

Interim results of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in patients with NSCLC in a phase 1 trial. (ASCO 2025) - P1 | "PDL1V monotherapy at the recommended expansion dose was generally well tolerated with a manageable safety profile. Encouraging preliminary efficacy in NSCLC was observed, independent of histology. Based on these results, further development of PDL1V in NSCLC is ongoing."

Clinical • P1 data • Anemia • Fatigue • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor

Dose optimization of PF-07248144, a first-in-class KAT6 inhibitor, in patients (pts) with ER+/HER2− metastatic breast cancer (mBC): Results from phase 1 study to support the recommended phase 3 dose (RP3D). (ASCO 2025) - P1 | "To inform the RP3D, we evaluated two pharmacokinetically distinguishable doses of PF-07248144 in combination with fulvestrant (FUL) from a phase 1 study in ER+/HER2− mBC in a dose expansion phase... Based on a thorough benefit–risk assessment of two pharmacokinetically distinguishable doses with sufficient number of pts and follow up, 5 mg QD PF-07248144 was identified as the optimal dose in combination with FUL with acceptable safety and encouraging activity. A pivotal phase 3 trial is planned to address the high unmet medical need in ER+/HER2− mBC after progression on CDK4/6i plus ET."

Clinical • Metastases • P1 data • P3 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Febrile Neutropenia • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Pneumonia • Solid Tumor • CDK4 • ER • HER-2