The combination of TQB2450 plus anlotinib generated responses and showcased a manageable safety profile in patients with recurrent or metastatic advanced endometrial cancer, according to data from the phase 2 TQB2450 II 08 trial.
The combination of TQB2450 plus anlotinib (AL3818) generated responses and showcased a manageable safety profile in patients with recurrent or metastatic advanced endometrial cancer, according to data from the phase 2 TQB2450 II 08 trial (NCT04574284) presented at the 2022 ESMO Congress.
Patients treated with the combination (n = 30) achieved an overall response rate (ORR) of 33.33% (95% CI, 17.29%-52.81%), with all responders experiencing a partial response. Additionally, 43.33% of patients had stable disease, 20.00% experienced disease progression, and 1 patient was not evaluable for response. The disease control rate (DCR) reported with the doublet was 76.67% (95% CI, 57.72%-90.07%).
“The treatment options after first-line chemotherapy for endometrial cancer are very limited,” lead study author Xiaohua Wu, MD, of the Gynecologic Oncology Department of Fudan University Shanghai Cancer Center in Shanghai, China, and colleagues, wrote in a poster presentation. “There is a substantial need for second-line and subsequent [treatments] for advanced endometrial cancer.”
The ongoing multicohort, open-label, multicenter TQB2450 II 08 trial is evaluating the multi-targeted TKI anlotinib in combination with the humanized, PD-L1–targeted monoclonal antibody TQB2450 in patients at least 18 years of age with pathologically confirmed recurrent or metastatic advanced endometrial cancer in whom 1 or 2 prior lines of therapy have failed. Patients were required to have an ECOG performance status of 0 or 1 and non–mismatch repair–deficient/microsatellite instability–high disease.
All enrolled patients are administered 12 mg of oral anlotinib per day on days 1 to 14 of each 21-day cycle, plus 1200 mg of TQB2450 on day 1 of each cycle.
The primary end point of the trial is ORR per independent review committee assessment. Secondary end points are comprised of investigator-assessed ORR, DCR, duration of response, progression-free survival (PFS), overall survival, and safety.
At the data cutoff of February 18, 2022, 30 patients had been enrolled to the trial. The median age of these patients was 57.5 years (range 47.0-78.0). Moreover, 56.67% of patients had an ECOG performance status of 1. At the time of diagnosis, 73.33% of patients had endometrial carcinoma, 20.00% had serous carcinoma, and 6.67% had mixed histology.
Regarding FIGO stage at baseline, 3.33% of patients had stage I disease, 16.67% had stage IA disease, 16.67% had stage IB disease, 6.67% had stage II disease, 10.00% had stage III disease, 3.33% had stage IIIB disease, 6.67% had stage IIIC disease, 6.67% had stage IIIC1 disease, 20.00% had stage IV disease, and 10.00% had stage IVB disease.
Forty percent of patients received prior pelvic radiation. Additionally, 63.33% of patients had received 1 prior line of systemic therapy and 36.67% had received at least 2 prior lines.
Additional data showed that the combination of TQB2450 and anlotinib resulted in a median PFS of 6.6 months (95% CI, 4.40-9.63).
Regarding safety, the most common any-grade treatment-emergent adverse effects (TEAEs) reported in at least 25% of patients who received the doublet included hypertension (63.33%), leukopenia (53.33%), increased thyroid-stimulating hormone (53.33%), diarrhea (46.67%), increased blood corticotropin (43.33%), palmar-plantar erythrodysesthesia syndrome (40.00%), decreased weight (36.67%), hypertriglyceridemia (33.33%), increased alanine aminotransferase (33.33%), hyperthyroidism (33.33%), increased aspartate aminotransferase (30.00%), hypercholesterolemia (26.67%), and hypothyroidism (26.67%).
The most common grade 3 TEAEs were hypertension (26.67%), palmar-plantar erythrodysesthesia syndrome (6.67%), increased thyroid-stimulating hormone (3.33%), hypertriglyceridemia (3.33%), and hypercholesterolemia (3.33%).
Wu X, Liang S, Chen X, et al. TQB2450 injection combined with anlotinib hydrochloride capsule in the treatment of advanced, recurrent or metastatic endometrial cancer: A multicohort, open label, multicenter phase II clinical trial: the TQB2450 II 08 trial. Ann Oncol. 2022;33(suppl 7):S802. doi:10.1016/j.annonc.2022.07.683