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First, take a lookHuaotaHB0025, The Phase II clinical trial disclosed this time isHB0025Combined ChemotherapyOneLater-line treatment or recurrent endometrial cancer, toDosage:20mg/kg,Q3WAdministrationCooperation4-6Round of chemotherapy. A total of __ patients were enrolled in the Phase II clinical trial disclosed this time.39People, among whom31Patients had been assessed by the cut-off date.
The current efficacy is also very good,OverallORRFor83.9%, Disease Control RateDCRFor100%, among which inpMMRIn patientsORRFor84%, indMMRIn patientsORRFor100%。AsComparison,The standard therapy for advanced or recurrent endometrial cancer is chemotherapy or chemotherapy combined with other treatments.PD-(L)1, OverallORRFor40%~68%. Therefore, from the current data,HB0025The efficacy is quite impressive.
In terms of safety, grade 3 treatment-related adverse events (TRAEs) Occurrence18Example (46.2%), the most common tertiaryTRAEs(≥10%) including neutropenia (30.8%)、Leukopenia (15.4%`) and thrombocytopenia (`10.3%). Any grade of immune-related adverse event (irAEs) Only occurs2Example (5.1%). Treatment-related serious adverse events (SAEs) Incidence rate is5.1%(2/39). NoneTRAELeading to treatment interruption or death. Bleeding events of any grade occurred.7Example (17.9%), all of which are1Level.
Take another look.PrometheusBNT327/PM8002, This TimeⅡPeriodClinical disclosure isPM8002First-line Combination Chemotherapy for Unresectable Malignant Pleural Mesothelioma。The dosing regimen is30 mg/kg,Q3W,IVCombined with Pemetrexed+Platinum-based(4-6period), followed byPM8002Maintenance treatment. As of2023Year10Month25Day, Total Enrollment31Example patients (median age58Year[Scope43-71Year]), among which80.6% ECOG PSScore is1Points,83.9%For patients with metastatic disease.23The case is malignant pleural mesothelioma (MPM),8The case is malignant peritoneal mesothelioma (MPeM). As of2024Year12Month20As of the daily data cutoff date, the median treatment exposure time was16.0Months (95% CI 8.1-19.5), the median follow-up time was19.3Months (95% CI 17.3-20.9)
Efficacy is as follows:1Example achieved complete remission (CR),9Example of partial remission (PR), the confirmed objective response rate (cORR) for43.5%;10Example: Disease stabilization (SD),1Example NonCR/NonPD(Not Complete Remission/Non-disease progression), Disease Control Rate (DCR) Da87.0%; Median Progression-Free Survival (mPFS) for11.8Months, median duration of response (mDOR) for11.8Months;12Total survival months (OS) Rate is82.6%(95% CI 60.1-93.1), MedianOSNot yet reached.
13Example of epithelioid histologyMPMIn patients:cORRFor30.8%,DCRFor84.6%,mPFSFor16.6Months; In8ExampleMPeMIn patients:6Example reachedPR,cORRFor75.0%;2ExampleSD,DCRFor100%; MedianDORFor16.3Months; MedianPFSAndOSNone of them have been reached,12MonthsOSRate is62.5%(95% CI 22.9-86.1). 6 cases of epithelioid histologyMPeMIn patients:cORRFor83.3%,DCRFor100%,mPFSFor19.5Months.
Safety: All patients experienced treatment-related adverse events (TRAEs),Among which93.5%(29/31) for3-4Level;16.1%(5Example) Occurrence3-4Grade Treatment-Related Serious Adverse Events (SAEs);16.1%(5Example) The occurrence of immune-related adverse events (irAEs), among which3.2%(1Example: For3-4Grade, Most CommonTRAEsFor decreased neutrophil count, decreased white blood cell count, proteinuria, anemia, decreased platelet count, and nausea;6Example: Patient due toTRAEsTreatment was discontinued, and no treatment-related deaths occurred.
Next is the recent blockbuster3SBio'sSSGJ-707, this yearASCOAbove, 3SBio announcedSSGJ-707 TreatmentAdvanced NSCLC Patient's First-Line Therapy II Phase Clinical。As of 2025 Year 1 Month 10 Day, already 83 Example NSCLC The patient received SSGJ-707 Treatment, with doses of 5mg/kg Q3W(n=31)、10mg/kg Q3W(n=34)、20mg/kg Q3W(n=12)、30mg/kg Q3W(n=6)。
Upon completion of at least one efficacy assessment 76 Among the patients,5 mg/kg Q3W、10 mg/kg Q3W、20 mg/kg Q3W And 30 mg/kg Q3W DoseBelow,ORRAndDCRRespectively 29.6% (8/27)/85.2% (23/27);61.8% (21/34)/97.1% (33/34),54.5% (6/11)/90.9% (10/11) ;25% (1/4)/75% (3/4)
SSGJ-707 10 mg/kg Q3WShowed good efficacy. In patients receiving this dose,Patients with non-squamous cell carcinoma and squamous cell carcinoma ORR Respectively 54.5%(12/22) And 75% (9/12);PD-L1 TPS 1%-49% And ≥ 50% Patient's ORR Respectively 57%(12/21) And 69%(9/13)。10 mg/kg Q3W Dose,Having completed at least two efficacy assessments25 PositionAmong the patients,ORR For72%(18/25),DCR For 100%(25/25)。ComparisonAK112Phase I clinical data shows comparable efficacy, butSSGJ-707Relatively High Toxicity
In terms of safety,78.3% Subject experienced treatment-related adverse events (TRAE),24.1% The patient experiences ≥3 Level TRAE. The most common TRAE Including hypercholesterolemia, hypertriglyceridemia, elevated alanine aminotransferase, and elevated aspartate aminotransferase.6% The patient was admitted due to TRAE And discontinuation of the drug。
Finally, let's take a look.ImmunotechIMM2510 1bClinical data on the clinical treatment of soft tissue sarcoma, after completing the dose escalation phase,Selected20mg/kg(Every2Once a week,Q2W)As an extended cohort dosing regimen. The enrolled patients wereFailed systematic treatment in advancedSTSPatient, including alveolar soft part sarcoma (ASPS,10Example), Undifferentiated Pleomorphic Sarcoma (UPS,5Example), Leiomyosarcoma (LMS,8Example), Synovial Sarcoma (SS,5Example) and other subtypes (1Example). The median number of previous treatment lines for the patients was2Line
OverallORR:7.4%(2ExamplePR);DCR:55.6%(2ExamplePR + 13ExampleSD, among which4Example: Tumor reduction).UPSCohort:ORR 20%(1/5),DCR 60%(1PR + 2SD)。LMSCohort:ORR 14.3%(1/7),DCR 42.9%(1PR + 2SD). Duration of relief (DOR):UPSNot reached,LMSFor3.68Months.
Safety:Treatment-related adverse events (TRAEs) Incidence Rate:96.6%(28/29),Where ≥3LevelTRAEsOccupy10.3%(3Example). CommonTRAEs(Any Grade): Infusion-related Reaction (IRR,37.9%) Thrombocytopenia (31%)ASTIncrease (27.6%)≥3LevelTRAEs:1Example: Thrombocytopenia,1Example: Elevated transaminase,1Example of decreased sensation. No treatment discontinuation.TRAEs。
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