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This phase I/II study enrolled 65 patients with castration-resistant prostate cancer (CRPC) previously treated with multiple therapies to evaluate the efficacy and safety of 6mg/kg (once every 3 weeks) and 9mg/kg (once every 3 weeks) doses.
Among 43 evaluable patients for efficacy, the unconfirmed objective response rate (ORR) was 27.9% (12/43, with 8 confirmed), and the disease control rate (DCR) was 95.3% (41/43). Median duration of response (DOR) has not been reached. At a median follow-up of 5.7 months, median radiographic progression-free survival (rPFS) was 8.3 months, with a 6-month rPFS rate of 86.6%.
Subgroup analysis showed ORR of 26.3% and 29.2% for 6mg/kg and 9mg/kg groups, respectively; DCRs were 100% and 91.7%, and 6-month rPFS rates were 88.7% and 80.0%. Patients with up to 3 prior treatments had an ORR of 33.3% and DCR of 77.8%, while those with ≥4 prior treatments had an ORR of 26.7% and DCR of 100%. Patients treated previously with Lu-177 showed ORR 25.0% and DCR 100%; those previously treated with immuno-oncology (IO) therapy showed ORR 33.3% and DCR 100%; PARP inhibitor-treated patients had ORR 16.7% and DCR 100%.
This study enrolled 43 histologically confirmed, treatment-na?ve, unresectable, HER2-negative gastric, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma patients to evaluate LM-302 (1.6mg/kg or 2.0mg/kg every 3 weeks, or 1.8mg/kg every 2 weeks) combined with toripalimab (240mg every 3 weeks or 3mg/kg every 2 weeks) for efficacy and safety.
Among 41 evaluable patients, at a median follow-up of 6.01 months, ORR was 65.9%, DCR was 85.4%, and median progression-free survival (PFS) and overall survival (OS) were not reached. In the subgroup with tumor CLDN18.2 expression ≥25% (IHC 2+/3+), ORR was 71.9% and DCR was 96.9%. In PD-L1 CPS <1 and PD-L1 CPS ≥1 subgroups, ORR was 63.3% and 77.8%, respectively.
No dose-limiting toxicities (DLT) were observed. Treatment-related adverse events (TRAE) occurred in 90.7% (39/43), with grade ≥3 TRAE in 37.2% (16/43).
As of December 23, 2024, the study enrolled 6 treated metastatic triple-negative breast cancer (TNBC) patients to evaluate JSKN-016 (4-8mg/kg every 3 weeks) for efficacy and safety.
Among 5 evaluable patients, ORR was 80.0%, DCR 100%, and PFS was not reached. Safety profile showed no interstitial lung disease or treatment-related discontinuations or deaths.
At this ASCO meeting, four clinical studies of Lukang Satuzumab were presented; three are introduced here.
The results announced this time are from an open-label, multicenter phase Ib/II study aimed at evaluating the safety and efficacy of 9MW2821 in combination with toripalimab in treatment-na?ve patients with locally advanced or metastatic urothelial carcinoma (la/m UC).
As of December 19, 2024, a total of 40 la/m UC patients were enrolled in the study. The overall response rate (ORR) was 87.5% (35/40), and the confirmed ORR (cORR) was 80% (32/40), including 3 complete responses. The disease control rate (DCR) was 92.5% (37/40). Median progression-free survival (PFS) and duration of response (DOR) had not been reached, with the 6-month PFS rate at 79.1% and the 3-month DOR rate at 100%. Additionally, in the subgroups with liver metastases, bladder cancer, and Nectin-4-negative expression, the ORRs were 88.2%, 94.4%, and 100%, respectively.
This phase Ib/II study evaluated the efficacy and safety of SHR-A1811 (4.8 mg/kg or 5.6 mg/kg every 3 weeks) combined with adebrelimab (1200 mg every 3 weeks) in 50 patients with unresectable or metastatic triple-negative breast cancer (TNBC).
In the phase Ib study (n=8), no dose-limiting toxicities (DLTs) were observed. The confirmed overall response rates (cORR) were 66.7% (2/3) for the 4.8 mg/kg dose group and 60.0% (3/5) for the 5.6 mg/kg dose group. The phase II portion enrolled 42 previously untreated TNBC patients to evaluate SHR-A1811 at the 4.8 mg/kg dose. At a median follow-up of 4.6 months, 39 patients were evaluable for efficacy, with an overall ORR of 66.7% (26/39), and an ORR of 77.8% (21/27) in the PD-L1 CPS ≥1 subgroup. SHR-A1811 combined with adebrelimab was well tolerated, with no new safety concerns identified. Regardless of HER2 or PD-L1 expression status, the combination therapy demonstrated promising antitumor activity.
Company: CCTQ
At this ASCO conference, three studies of TQB2102 were selected, with data disclosed for two of them.
Phase I Study in Solid Tumors: As of October 1, 2024, a total of 181 patients with solid tumors (80 with metastatic breast cancer, 37 with colorectal cancer, 23 with gastric cancer, and 41 with other cancers) were enrolled and treated. Among them, 41 participated in the dose-escalation study (1.5–9 mg/kg), and 140 participated in the dose-expansion study (6 mg/kg or 7.5 mg/kg). Results showed that with a median follow-up of 8.15 months, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Among 165 evaluable patients, the objective response rate (ORR) was 41.2% (all partial responses). In addition, 7 patients with HER2-positive breast cancer brain metastases achieved partial responses, with 1 patient achieving complete response after 4 treatment cycles.
Phase Ib Study in HER2-Low Breast Cancer: A total of 73 chemotherapy-treated patients were enrolled and treated with TQB2102 monotherapy (37 at 6 mg/kg, 36 at 7.5 mg/kg). With a median follow-up of 7.16 months, the overall ORR was 53.4% (39/73), with 48.7% in the 6 mg/kg group and 58.3% in the 7.5 mg/kg group; the disease control rate (DCR) was 86.3% (63/73). ORR was 54.0% (27/50) in the HR-positive subgroup and 52.2% (12/23) in the HR-negative subgroup. In the 7.5 mg/kg group, ORR was 66.7% (14/21) for HR-positive patients and 46.7% (7/15) for HR-negative patients. Among patients previously treated with ADCs, ORR was 44.4% (4/9).
Safety: The incidence of treatment-related adverse events (TRAEs) was 97.3% (71/73), with grade ≥3 TRAEs in 41.1% (30/73), and serious adverse events (SAEs) in 17.8% (13/73). No cases of interstitial pneumonia were reported.
Drug target + type: PD-L1 ADC
The disclosed Phase I study is divided into two parts. Part 1 enrolled 18 patients with advanced/metastatic malignant solid tumors who were refractory or ineligible for standard treatments, including 12 with NSCLC, 1 with head and neck squamous cell carcinoma, 1 with cervical squamous cell carcinoma, 1 with thymic squamous cell carcinoma, 1 with nasopharyngeal carcinoma, 1 with uterine sarcoma, and 1 with small cell lung cancer. The investigator-assessed ORR was 31.3%.
Part 2 enrolled patients with advanced/metastatic NSCLC refractory to standard treatment, including 15 with squamous NSCLC and 6 with non-squamous NSCLC. The investigator-assessed ORR and DCR were 38.1% and 81.0%, respectively, with 8 patients (6 squamous NSCLC and 2 non-squamous NSCLC) achieving partial response. The results suggest that HLX43 is well tolerated at different doses and shows preliminary efficacy in patients with advanced solid tumors, including NSCLC, who have failed standard treatments.
This is the first time phase I data of ozuriftamab vedotin for melanoma treatment has been released at ASCO. The study included 5 patients with advanced cutaneous or uveal melanoma who had previously received vinca alkaloid binding site inhibitor therapy and were unresponsive to all standard treatments.
Among these 5 patients, 4 achieved objective responses in target lesions per RECIST v1.1 criteria. Two patients maintained disease control: one achieved a complete response lasting over 5 years, and another had a response duration of more than 1 year. No patients discontinued treatment due to adverse events.
ROR2 expression in biopsy samples was assessed by immunohistochemistry (IHC). The patient who achieved CR had a biopsy sample strongly positive for ROR2. All other biopsy samples showed low or negative ROR2 staining in malignant cells.
The C5851001 study included a phase I safety lead-in cohort (Part D). As of December 20, 2024, 14 patients with PD-L1 CPS ≥1 and previously untreated recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) were enrolled.
In Cohort 1 (n=8), patients received PD-L1V (1.25 mg/kg every 3 weeks, adjusted ideal body weight [AIBW]) combined with pembrolizumab (200 mg every 3 weeks). After safety confirmation, Cohort 2 (n=8) received PD-L1V (1.5 mg/kg every 3 weeks, AIBW) combined with pembrolizumab (200 mg every 3 weeks).
Among 14 evaluable patients, ORR was 50.0%, with a complete response (CR) rate of 21.4%. Median duration of response (DOR) had not been reached.
No dose-limiting toxicities (DLTs) were observed. The most common treatment-related adverse events (TRAEs) were fatigue and nausea (50.0% each), peripheral sensory neuropathy (35.7%), diarrhea (28.6%), and anemia, constipation, decreased appetite, muscle spasms, pneumonia, and pyrexia (each 14.3%).
Initial data from the dose-expansion Cohort B2 of the phase I/II GCT1184-01 study evaluating single-agent Rina-S in heavily pretreated endometrial cancer (EC) patients was presented. As of November 22, 2024, 64 EC patients (median prior lines of therapy: 3) were treated with Rina-S—22 received 100 mg/m2, and 42 received 120 mg/m2.
At a median follow-up of 18.7 weeks, unconfirmed ORR was 50% in the 100 mg/m2 group (including 2 CRs) and 45.5% in the 120 mg/m2 group. DCR was 100% and 81.8% in the two groups, respectively. Of 11 responders in the 100 mg/m2 group, 9 (81.8%) maintained response, while 12 of 15 responders (80.0%) in the 120 mg/m2 group had ongoing responses.
Safety profiles across dose groups were similar, mainly hematologic toxicity and grade 1–2 gastrointestinal symptoms (nausea, vomiting, decreased appetite). Grade 3–4 hematologic toxicities included neutropenia (48.4%), anemia (35.9%), and thrombocytopenia (21.9%). Dose reductions occurred in 15.6%, treatment discontinuation in 3.1%, and serious TEAEs in 37.5%. One Grade 5 TEAE related to comorbidities was reported in the 120 mg/m2 group (investigator-determined); no treatment-related deaths occurred in the 100 mg/m2 group.
This first-in-human study was a single-center, open-label, non-randomized trial. As of December 31, 2024, 25 patients with EGFR-positive advanced gastrointestinal tumors (18 colorectal cancer, 7 gastric cancer), who had progressed after at least one line of standard therapy (12 received ≥3 lines), were enrolled. The study evaluated the safety, tolerability, and preliminary efficacy of SYS6010 (3.2 mg/kg every 2 weeks) in combination with the ATM inhibitor SYH2051 (40 mg or 80 mg daily).
Among 6 evaluable gastric cancer patients, 3 achieved PR and 3 had SD, yielding an ORR of 50% and DCR of 100%. Median PFS was about 5.8 months (data immature), with 3 patients still on treatment. Among 18 colorectal cancer patients (9 with KRAS-mutant, 9 wild-type), preliminary analysis showed a median PFS of ~4.2 months in the KRAS wild-type subgroup (data immature).
Common TRAEs included hematologic toxicity, gastrointestinal symptoms, and fatigue. Grade ≥3 TRAEs occurred in 48% (12/25), with no treatment-related deaths reported.
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