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Guide
Cisplatin-based combination chemotherapy is the standard of care for locally advanced or metastatic urothelial carcinoma (Ia/mUC), but there are still problems such as
toxicity, lack of long-lasting response, and incompatibility in some patients.
Therefore, first-line (1L) regimens
that are also effective and tolerated in patients who are not eligible for cisplatin need of be sought.
One study explored the efficacy
of enfortumab vedotin (EV) and pembrolizumab in combination as 1L therapy in UC patients not for cisplatin.
The results of the relevant research were recently published in the Journal of Clinical Oncology, and the medical pulse is summarized as follows
.
EV and pembrolizumab are both effective monotherapy therapies for Ia/mUC, and based on their complementary effects on the immune system, the combination of the two may enhance antitumor activity, and it is worth exploring the efficacy and safety
of this regimen as a 1L regimen in patients with Ia/mUC who are not suitable for cisplatin.
In this ongoing phase I.
b/II.
multicenter, open-label study, patients with cisplatin-in-not Ia/mUC (≥ 18 years of age, histologically confirmed, ECOG PS score of 0 or 1, investigator-assessed life expectancy >3 months) received EV (1.
25 mg/kg, days 1 and 8) plus pembrolizumab (200 mg, day 1) for 1L treatment cycles
every 3 weeks.
The primary endpoint was safety
.
Important secondary study endpoints included confirmed objective response rate, duration of response (DOR), and overall survival (OS).
A total of 45 patients received EV plus pembrolizumab
.
The patients were predominantly male (80.
0%), with a median age of 69 years, of which 35.
6% ≥ 75 years
.
84.
4% of patients had visceral metastases, of which 31.
1% had liver metastases
.
The most common treatment-related adverse events (TRAEs) were peripheral sensory neuropathy (55.
6%), fatigue (51.
1%), and hair loss (48.
9%)
.
Twenty-nine patients (64.
4%) developed grade 3 or more TRAEs, the most common of which were asymptomatic lipase elevation (17.
8%), maculopapular rash (11.
1%), and fatigue (11.
1%)
.
One patient died
of TRAE.
Figure 1 Summary table of TRAEs
After treatment (median treatment cycle 9), the objective response rate confirmed by investigators was 73.
3% (95% CI 58.
1% to 85.
4%), with 7 (15.
6%) patients achieving complete response and 26 (57.
8%) patients achieving partial response
.
Fig.
2 Changes in the patient's target lesion compared to baseline
At a median follow-up of 20.
0 months, the median DOR was 25.
6 for
patients.
At 24.
9 months' follow-up, median progression-free survival (PFS) and median OS were 12.
3 months and 26.
1 months
, respectively.
Fig.
3 DOR, progression-free survival (PFS), and OS results of patients
EV plus pembrolizumab is a 1L platinum-free regimen that has shown encouraging antitumor activity and a controlled safety profile in patients with Ia/mUC who are not eligible for cisplatin, even in patients with liver metastases.
After treatment, most patients had tumor lesions that shrank and had median DOR and OS for more than 2 years
.
This joint scheme has certain application prospects
.
References
Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE.
Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer.
J Clin Oncol.
2022 Aug 30:JCO2201643.
