The 2025 ASCO Conference has concluded.Insight Database Reviews 10 FIC Drug Clinical Trials(In no particular order)`, for your reference.`*Due toWenDue to limited space, it is difficult to include all FIC new drug research results. Welcome to use the Insight database for inquiries. Lixin Pharmaceutical Technology (Shanghai) Co., Ltd.: LM-108LM-108 is a novel Fc-optimized anti-CCR8 monoclonal antibody. The aggregated analysis results of two Phase I/II clinical trials of this drug were presented at this year's ASCO meeting to evaluate the efficacy of LM-108 in combination with anti-PD-1 therapy.Pancreatic CancerEfficacy and safety of patients.A total of 80 patients from China and Australia were treated in the two trials. The median follow-up time was 10.48 months, and among the 74 evaluable patients,ORR was 20.3%, DCR was 62.2%. Median DoR was 5.49 months, PFS was 3.12 months, and OS was 10.02 months.。Among 45 patients who experienced disease progression during or after prior first-line treatment，ORR was 24.4%, DCR was 71.1%, median DoR was 6.93 months, and PFS was 4.86 months., OS not reached.The 12-month OS rate was 51.6%.Among them, 9 patients with high CCR8 expression(7 cases with liver metastases at baseline)ORR was 33.3%, DCR was 77.8%, median PFS was 6.90 months, and OS was 9.15 months.76 patients reported TRAEs. Common TRAEs（≥25%）Including aspartate aminotransferase（AST）Elevation, Alanine Transaminase（ALT）Elevation, anemia, rash, fever, decreased platelet count, and increased conjugated bilirubin. ≥Grade 3 TRAEs occurred in 42 patients, with the most common events being...（≥5%）For elevated lipase, elevated ALT, elevated AST, immune-mediated enterocolitis, hypokalemia, and rash. Arvinas/Pfizer: VepdegestrantVepdegestrant is a next-generation oral selective estrogen receptor degrader developed based on PROTAC technology.（SERD）, which can directly mediate ER protein degradation by activating the intracellular ubiquitin-proteasome system.The result of the Phase III clinical trial VERITAC-2 for this drug was announced at the ASCO meeting. This is a Phase III, randomized, open-label, multi-center trial designed to evaluate disease progression in patients with advanced disease who have previously received endocrine-based therapy.HR+/HER2- Advanced Breast CancerComparison of the Efficacy and Safety of PF-07850327 versus Fulvestrant in Subjects.Results showed that, for the subgroup of ER+/HER2- advanced breast cancer patients carrying ESR1 mutations, Vepdegestrant versus FulvestrantDemonstrated statistically significant and clinically meaningful improvement in PFS, compared with fulvestrant, VepdegestrantReduced the risk of disease progression or death by 43%。According to the BICR assessment, the Vepdegestrant groupMedian PFS was 5.0 months, Fulvestrant group was 2.1 months.In patients harboring ESR1 mutations, VepdegestrantPFS benefit superior to fulvestrant was observed in all pre-specified subgroups.. The trial in the intent-to-treat (ITT) The improvement in PFS for the population did not reach statistical significance, with a median PFS of 3.7 months for Vepdegestrant and 3.6 months for Fulvestrant.Analysis of secondary endpoints further validated the efficacy advantage of Vepdegestrant in the ESR1 mutation subgroup.Clinical Benefit Rate in the Vepdegestrant Group（CBR）Reached 42.1%, significantly higher than the 20.2% in the fulvestrant group; ORR also demonstrated a significant advantage, with ORR in the two groups being 18.6% vs. 4.0%, respectively.Exploratory analysis of OS shows that the current data has not yet reached the preset maturity.In terms of safety, Vepdegestrant was generally well-tolerated, with a safety profile consistent with previous study results, and most TEAEs were low-grade. The incidence and severity of gastrointestinal adverse events in the Vepdegestrant group were low. The three most common TEAEs in the Vepdegestrant group were fatigue, increased alanine aminotransferase, and increased aspartate aminotransferase. Among patients taking Vepdegestrant, the incidence of TEAEs leading to treatment discontinuation was 2.9%, while among those taking fulvestrant, it was 0.7%. Johnson & Johnson: JNJ-78278343JNJ-78278343 is a first-in-class bispecific T-cell engager antibody that simultaneously targets KLK2 and CD3 on T cells. The data presented here are from a study evaluating the drug's efficacy in treatment.Metastatic Castration-Resistant Prostate Cancer（mCRPC）Phase I Study（NCT04898634）New data.In the RP2D efficacy group（n=33），42.4% of patients with prostate-specific antigen（PSA）A 50% or greater reduction, with a median rPFS of 7.9 months, of which 21.2% of patients are still under treatment.
In terms of safety, the most common TRAE was grade 1/2 infusion-related reactions, with grade 1 CRS manifested only as fever.(Without the use of steroids or tocilizumab), no reports of higher-grade CRS. No TRAEs leading to treatment discontinuation or dose reduction were reported, and no immune effector cell-associated neurotoxicity syndrome was observed. (ICANS)Grade 3 TRAEs were uncommon, with 4.4% of patients reporting transient AST/ALT elevation and neutropenia. No dose-limiting toxicity was reported.
DZD8586 is a first-in-class, fully blood-brain barrier penetrant, non-covalent LYN/BTK dual-target inhibitor. Data on this drug in heavily pretreated patients were presented at the ASCO meeting.Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma（CLL/SLL）And Relapsed/RefractoryDiffuse Large B-Cell Lymphoma（r/r DLBCL）Two research results.In terms of CLL/SLL, as of April 4, 2025, the study enrolled a total of 51 patients with relapsed/refractory disease.（r/r）CLL/SLL Patients Treated with DZD8586. Results showed that, at the recommended Phase III dose（RP3D）At 50 mg, DZD8586 demonstrated favorable anti-tumor efficacy in heavily pretreated patients with CLL/SLL, and its safety was manageable:ORR as high as 84.2%, respectively observed in patients previously treated with BTK inhibitors, Bcl-2 inhibitors, or BTK degraders82.4%, 83.3%, and 50% tumor response rates；
In carrying the classic BTK resistance mutation（C481X）, as well as patients with other BTK mutations, including BTK kinase inactivating mutations,Tumor relief was observed in all cases.；
Durable responses observed, with a median duration of response expected at 9 months（DOR）Rate is 83.3%；
Median PFS is not yet mature, with 78.9% of patients still continuing on DZD8586 treatment.
In terms of r/r DLBCL, the enrolled patients had previously received 1 to 4 lines of systemic treatment, and the treatment regimens all included chemotherapy-immunotherapy based on anthracycline combined with anti-CD20 monoclonal antibody. Research data show that at doses of 50 mg and 75 mg,DZD8586 Demonstrates Promising Antitumor Activity and Safety in r/r DLBCL，And tumor responses were observed in both the GCB subtype and non-GCB subtype.。
BioNTech/Biotheus: PM8002PM8002（BNT327）It is a PD-L1/VEGFA bispecific antibody independently developed by Biotheus Inc. In November 2024, BioNTech$950 millionAcquisition of Biotheus Inc.,Acquire the entire pipeline of drug candidates, including PM8002In June 25, BMS usedUSD 11.1 billionBiotheus Inc. has reached a cooperation agreement with BioNTech to jointly develop and commercialize PM8002 worldwide.The results announced this time are from a Phase II clinical trial of PM8002 conducted in China. As of October 25, 2023, a total of 31 patients were enrolled, with 23 cases of pleural mesothelioma.(MPM) , 8 cases were peritoneal mesothelioma(MPeM)As of December 20, 2024, the median exposure duration was 16.0 months, and the median follow-up time was 19.3 months.Among 23 MPM patients, 1 achieved complete remission. (CR)`, 9 cases achieved partial remission` (PR)，cORR is 43.5%. 10 patients achieved stability (SD), 1 case of non-complete remission/non-progression(NCR/NPD)，DCR was 87.0%. Median PFS was 11.8 months, and median DOR was 11.8 months.。The 12-month OS rate was 82.6%., the median OS has not been reached yet. Among the 13 patients with epithelioid MPM,cORR was 30.8%, DCR was 84.6%, and mPFS was 16.6 months.。
Among 8 patients with MPeM, 6 achieved PR as the best overall tumor response.cORR is 75.0%. 2 cases of SD,DCR is 100%；Median DOR was 16.3 monthsThe median PFS and OS have not been reached yet,The 12-month OS rate was 62.5%.. Six patients with epithelioid histology MPeMcORR was 83.3%, DCR was 100%, and median PFS was 19.5 months.
All patients experienced TRAEs, with 93.5% experiencing grade 3-4 events. Five patients had grade 3-4 treatment-related SAEs. Five patients developed irAEs, one of which was grade 3-4. The most common TRAEs included decreased neutrophil count, decreased white blood cell count, proteinuria, anemia, decreased platelet count, and nausea. Six patients discontinued treatment due to TRAEs; no treatment-related deaths occurred. Nine patients remain on treatment.
SHR-2017 is a RANKL/NGF bispecific antibody independently developed by Hengrui Pharma, intended for the treatment ofPrevention of Bone-Related Events in Patients with Solid Tumor Bone Metastases and Multiple MyelomaAt this year's ASCO conference, Hengrui Pharma unveiled for the first time preliminary pharmacokinetic, pharmacodynamic, efficacy, and safety results from a Phase Ib clinical study of SHR-2017 in breast cancer patients with bone metastases.As of December 31, 2024, a total of 22 patients have been enrolled and treated.(36% of patients had previously used bone-targeted agents (BTA); the pain intensity at sites of bone metastases was assessed using a numerical rating scale, with an average score of 4.17.)After a single dose, the median time to reach peak blood concentration of SHR-2017 is 7 days, with an average half-life of 11.4 days and an average clearance rate.(CL/F) 0.88 liters/day.Among 12 patients who had not previously used BTA,N-terminal peptide corrected by creatinine in urine (uNTx/Cr)InSignificantly reduced in the first cycle，And this reduction persists.；Week 5（C2D1）Compared to BaselineThe median reduction was 83.0%.; toWeek 13 (C4D1), among 8 patients who have not used BTA,The median reduction in uNTX/Cr was 78.7%.。Assess pain using a numerical rating scale for all patients.The daily pain score continued to decrease throughout the first cycle., the average pain and worst pain in the second week relative to baselineThe average reductions were 1.95 and 1.90, respectively.. By the 4th week,The reductions were 2.46 and 2.45, respectively.。7 patients experienced treatment-related adverse events(Grade 1, n = 6; Grade 2, n = 1), the most common is parathyroid hormone.(PTH) Elevated, with 1 case of Grade 2 TRAE being rash. No TRAE led to discontinuation of the drug.Petosemtamab is a first-in-class EGFR/LGR5 bispecific antibody. The results announced this time are from a study combining this drug with pembrolizumab.First-line Treatment for PD-L1+ Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck(HNSCC) Phase II Clinical Trial（NCT03526835）。As of February 27, 2025, a total of 45 patients had been treated in the trial, and as of the data cutoff date, 14 patients were still receiving treatment. Among them, 43 patients(Patients who received ≥1 dose of treatment and had ≥1 post-baseline scan, or discontinued treatment early due to disease progression or death)Efficacy can be evaluated, as assessed by the investigator.ORR was 63%, with 6 complete responses and 21 partial responses; median PFS was 9 months, with median duration of response and median OS not yet reached, and the 12-month overall survival rate was 79%. Responses were observed across patients with different PD-L1 levels.。In terms of safety, the combination therapy was generally well-tolerated.No significant overlapping toxicity was observed. TEAEs were reported in 45 patients, with 60% of patients experiencing Grade ≥3 TEAEs.38%(All are G grade)And 7%(Grade G3)Patients reported infusion-related reactions, which mainly occurred during the first infusion and have all been alleviated. Bicara Therapeutics：Ficerafusp alfaFicerafusp alfa is a first-in-class bispecific antibody targeting EGFR and TGF-β. Data presented at this year’s ASCO meeting showcased its combination with pembrolizumab for the treatment of recurrent or metastatic...Patients with Squamous Cell Carcinoma of the Head and Neck (HNSCC) Phase I/Ib Trial（NCT04429542）Latest Results of the Expanded Cohort.In the evaluable efficacy population of HPV-negative patients（n=28）In China, patients with efficacy relief（n=15）TheThe median DOR was 21.7 months, the median OS was 21.3 months, the 2-year OS rate was 46%, and the confirmed ORR was 54%, with 21% of patients achieving complete remission.。80% The remitters achieved deep remission.(Tumor reduction ≥80%)，The disease control rate was 89%, with a median PFS of 9.9 months.。
In addition, the safety results are consistent with the known safety profile of Ficerafusp alfa plus pembrolizumab. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase II/III clinical trial for first-line recurrent/metastatic HNSCC patients.
IMA203 is an autologous TCR-T therapy targeting PRAME. At this year's ASCO meeting, Immatics presented the drug's data in 33 heavily pretreated patients in an oral presentation.Metastatic MelanomaLatest Results from the Phase Ib Clinical Trial Conducted in Patients.- Among all melanoma patients,The PFS rates at 6 months and 12 months were 53% and 27%, respectively.，The OS rate in December was 61%., 42% of patients achieved deep remission(Tumor reduction ≥50%)，Median PFS was 12.9 months, cORR was 56%, mDOR was 12.1 months, mPFS was 6.1 months, and mOS was 15.9 months.；
In the subgroup of cutaneous melanoma,cORR was 50%, mDOR was not reached at a median follow-up time of 16.7 months, mPFS was 6.0 months, and mOS was 13.9 months.；
In the uveal melanoma subgroup,cORR was 67%, mDOR was 11.0 months, mPFS was 8.5 months, and mOS was 16.2 months.。
Transformation analysis shows,IMA203 treatment can reduce systemic metastatic target lesions., including refractory metastases in the liver, lungs, lymph nodes, abdomen/peritoneum, skin, etc. Some individual lesions completely regressed.（-100%）。
In terms of safety, the most common treatment-related adverse events were the expected cytopenias associated with lymphodepletion. The expected and manageable CRS was mostly grade 1 and 2. No patients experienced prolonged CRS. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) The incidence is low, controllable, and mostly mild. No grade 5 events related to IMA203 were observed.
ZG006 is a trispecific T-cell engager targeting two distinct DLL3 epitopes and CD3, and it is also the world's first trispecific antibody targeting the DLL3 antigen.（DLL3×DLL3×CD3）At this year's ASCO meeting, Zelgen announced the latest data from three clinical studies of the drug.The first item is ZG006 monotherapy inRefractory Advanced Small Cell Lung Cancer（SCLC）Phase II Dose Optimization Clinical Study in Patients（ZG006-002）As of February 14, 2025, a total of 48 patients with third-line or higher small cell lung cancer were randomly assigned in a 1:1 ratio to receive ZG006 10 mg Q2W or 30 mg Q2W treatment and completed at least one efficacy evaluation.In terms of efficacy, based on the IRC assessment,The ORR for the 10 mg and 30 mg groups was 62.5% and 58.3%, respectively, and the DCR was 70.8% and 66.7%, respectively.; Median PFS and median DoR are not yet mature. In addition,Demonstrates good anti-tumor activity in patients with low DLL3 expression or baseline brain metastases.。
In terms of safety, both groups showed good overall tolerability and safety, with no permanent discontinuation of treatment due to TEAEs. Common TRAEs included fever, CRS, and laboratory abnormalities, with the majority being grade 1-2. In the 10 mg and 30 mg groups, 5 and 9 patients, respectively, experienced TRAEs of grade 3 or higher. Additionally, most CRS events were grade 1-2, primarily occurring during the first two treatment cycles, and resolved quickly after symptomatic treatment.
The second item is ZG006 inAdvanced Small Cell Lung Cancer or Neuroendocrine CarcinomaA Dose-Escalation and Expansion Phase I/II Clinical Study of Tolerability, Safety, Efficacy, and Pharmacokinetics in Patients（ZG006-001）As of February 14, 2025, a total of 47 patients(43 patients with small cell lung cancer, 4 patients with neuroendocrine carcinoma)Patients received ZG006 Q2W treatment with doses ranging from 0.1 mg to 100 mg, with the first dose at 10 mg and above being a 1 mg titration dose. All patients completed at least one efficacy assessment.
In terms of efficacy, according to the investigator's assessment, ZG006 monotherapy demonstrated favorable anti-tumor activity in patients with advanced small cell lung cancer across multiple dose levels, particularly at doses of 10 mg, 30 mg, and 60 mg Q2W.The confirmed ORR was 75.0%, 53.8%, and 58.3%, respectively, and the DCR was 75.0%, 76.9%, and 83.3%, respectively.At the time of the assessment cutoff, PFS and DoR were not yet mature.
In terms of safety, all 47 patients experienced TRAEs, most of which were grade 1-2. Common TRAEs included CRS, fever, abnormal laboratory results, etc., and most were resolved or alleviated after symptomatic treatment.
The third item is ZG006 inAdvanced Neuroendocrine CarcinomaPhase II Dose Expansion Clinical Study in Patients（ZG006-003）As of March 21, 2025, a total of 46 patients with second-line or higher neuroendocrine carcinoma received ZG006 treatment. They were randomly assigned in a 1:1 ratio to receive either 10 mg Q2W or 30 mg Q2W, with an initial titration dose of 1 mg for the first administration.
In terms of efficacy, there were 8 and 9 evaluable subjects in the 10 mg Q2W and 30 mg Q2W groups, respectively, based on investigator assessment.The unconfirmed ORR was 12.5% and 55.6%, respectively, and the DCR was 37.5% and 77.8%, respectively.;mPFS and mDoR are not yet mature.
In terms of safety, 87.0% of subjects experienced TRAEs, the vast majority being grade 1 or 2.
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