The evaluation data of 7 types of tumors were evaluated by the first paboliju single anti-combined lunvatinib.

In phase II LEAP-004 trials, the objective remission rate (ORR) of LENVIMA combined with KEYTRUDA was 21.4% (95% confidence interval( CI: 13.9-30.5) in patients with non-removable or advanced melanoma who had developed disease progression after previous treatment with anti-PD-1/PD-L1.
In Phase II LEAP-005 trials, it was used for past treatments of triple-negative breast cancer (TNBC), ovarian, stomach, and colorectal cancer (non-microsatellite high instability (non-MSI-H)/misalmutation repair gene normal (pMMR),) In patients with polymorphic glioblastoma (GBM) and bile tube cancer (BTC), the ORR range of LENVIMA combined with KEYTRUDA was 9.7-32.3% (95% CI: 2.0-51.4).
RESULT-004 (Summary LBA44) and LEAP-005 (Summary LBA41) results were received as a delayed publication summary at the 2020 Annual Meeting of the European Society of Oncology (ESMO) and presented and reported at the meeting.
(MEL): Preliminary results of LEAP-004 (summary LBA44) of advanced melanoma (MEL): LEAP-004 after treatment with PD-1 or PD-L1 inhibitors (ClinicalTrials.gov, NCT03776136) is a phase II, single-arm, open trial evaluating LENVIMA combined with KEYTRUDA in patients with non-removable or advanced melanoma who developed the disease after receiving anti-PD-1/PD-L1 treatment for 12 weeks.
patients are given oral LENVIMA 20 mg once daily, while intravenous infusion keyTRUDA 200 mg, once every 3 weeks, lasts 35 cycles (approximately 2 years) until there is insatiable toxicity or disease progression.
main endpoint is ORR, which is evaluated by the Independent Centre for Blindness Review (BICR) on the basis of the Solid Tumor Efficacy Evaluation Criteria (RECIST) v1.1.
secondary endpoints include progress-free lifetime (PFS) and mitigation duration (DOR), evaluated by BICR based on RECIST v1.1), total lifetime (OS), and security.
the data deadline (10 June 2020), a total of 103 patients were admitted to the group and treated.
12 months (range: 8.7-15.6) and the overall ORR of LENVIMA joint KEYTRUDA (assessed by BICR) was 21.4% (n-2) 22) (95% CI: 13.9-30.5), with a full mitigation rate of 1.9% (n-2) and a partial mitigation rate of 19.4% (n-20).
in the overall study population, the medium DOR was 6.3 months (range: 2.1 plus to 11.1 plus), and 72.6% (95% CI:46.2-87.6) of patients with remission lasted at least 6 months.
PFS was 4.2 months (95% CI: 3.5-6.3), 73.8% of patients had disease progression or death, and 9-month PFS was 26.2% (95% CI: 17.4-35.9).
13.9 months (95% CI: 10.8-NR), 44.7% of patients died, and 9 months OS was 65.4% (95% CI: 55.2-73.8).
exploratory analysis showed that, specifically, in 29 patients who developed the disease after receiving anti-PD-1/L1 treatment and anti-CTLA-4 treatment, the ORR (assessed by BICR) was 31% (95% CI:15.3-50.8), with a total remission rate of 3.4% (n-1) and a partial remission rate of 27.6% (n-8).
in these patients, the disease control rate (DCR, assessed by BICR) was 62.1% (95% CI:42.3-79.3).
in the overall study population, the DCR (assessed by BICR) was 65% (95% CI:55.0-74.2).
treatment-related adverse events (TRAEs) cause 7.8% of patients to terminate LENVIMA and/or KEYTRUDA treatment.
44.7% of patients had level 3-5 TRAE (level 3: 39.8%; level 4: 3.9%; level 5: 1.0%), and 18.4% had severe TRAE.
the most common (≥30%) of the population in the study group had high blood pressure (56.3%), diarrhea (35.9%), nausea (34.0%), hypothyroidism (33.0%) and loss of appetite (31.1%).
LEAP-005: Lenvatinib Joint Paboli Pearl Monoantitor for the treatment of patients with previously treated advanced solid tumors Phase II study (summary LBA41) LEAP-005 (ClinicalTrials.gov, NCT03797326) is a phase II, single-arm, open trial evaluated in patients with previously treated advanced solid tumors.
the study was TNBC, ovarian, stomach, colorectal (non-MSI-H/pMMR), GBM, and BTC patients.
patients are given oral LENVIMA 20 mg once daily, while intravenous infusion keyTRUDA 200 mg, once every 3 weeks, lasts 35 cycles (approximately 2 years) until there is insatiable toxicity or disease progression.
main endpoints are ORR (evaluated by BICR based on RECIST v1.1 or Neuro-Oncology Efficacy (RANO) standard (GBM only) and safety.
secondary endpoints include DCR (evaluated by BICR on the basis of RECIST v1.1 or RANO (for GBM only), DOR (evaluated by BICR on the basis of RECIST v1.1 or RANO only for GBM), PFS (evaluated by BICR on the basis of RECIST v1.1 or RANO only) and OS.
the data deadline (April 10, 2020), a total of 187 patients were grouped and treated.
the medium follow-up duration of 8.6 months (range: 1.9-13.1), orR confirmed by 6 different tumor types and results of effectiveness and safety: the most common (≥20%) of any level of TRAP in the overall study population was hypertension (≥20%) 39.0%), fatigue (29.4%), diarrhea (26.7%), loss of appetite (25.1%), hypothyroidism (27.8%) and nausea (21.9%).
based on these preliminary results, the trial will be extended to about 100 patients in each team.
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