A recent Phase 3 clinical trial published in Lancet Oncology has identified that camrelizumab used in combination with gemcitabine and cisplatin (chemotherapy) improves progression-free survival (PFS) for those diagnosed with recurrent or metastatic nasopharyngeal carcinoma when compared to placebo and gemcitabine.
Researchers are hopeful that this study could result in this treatment combination becoming the new standard of care for this patient population.
Phase 3 Trial
This Phase 3 trial included 343 patients. These individuals were randomized to either receive the investigative combination therapy (134 patients) or placebo with gemcitabine (129 patients). Every participant had distant metastases. The median age for the participants was 49 (although ages ranged from 18 to 75) and most had non-keratinizing undifferentiated histology. Additionally, two-thirds had concurrent chemoradiotherapy. No patient had ever received prior therapies and had an ECOG performance of 0 or 1.
Those receiving the camrelizumab treatment were given 200mg of the treatment and gemcitabine at 1,000mg/m2 on the first day. They were given the same dose of gemcitabine on day 80. Additionally, they were given cisplatin at 80mg/m2 on the first day and by IV once every 3 weeks for a period of 4-6 cycles. Camrelizumab was also given on the first day of the 3-week cycle for the rest of the study’s duration.
The treatment was stopped if there were unacceptable levels of toxicity or radiographic progression.
Here are some of the most notable findings-
- PFS for the treatment group was 9.7 months
- PFS for the placebo group was 6.9 groups
- Statistically significant survival benefit for the treatment group was found
- Objective response was 87.3% in the treatment group
- Objective response was 80.6% in the placebo group
- Duration of response was 8.5 months for the treatment group
- Duration of response was 5.6 months for the placebo group
AEs
94% of patients in the treatment group experienced a grade 3 AE or higher. Additionally, 91% of those in the placebo group experienced a grade 3 or higher AE. The most common AE’s that were at least this grade were-
Treatment group
- Low white blood cell count – experienced by 66%
- Low neutrophil count – experienced by 64%
- Anemia – experienced by 40%
- Low platelets- experienced by 40%
Placebo group
- Low white blood cell count – experienced by 70%
- Low neutrophil count – experienced by 66%
- Anemia – experienced by 44%
- Low platelets- experienced by 40%
Serious AEs were present for 36% of the treatment group and 29% of the placebo group. Additionally, 7% of those in the treatment group sadly passed away, as did 5% of those in the placebo group.
The researchers have concluded that this combination therapy is extremely beneficial for patients and should be considered as the newest standard of care.
You can read more about this study and this treatment here.
Reference
Yang Y, Qu S, Li J, et al. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021;22(8):1162-1174. doi:10.1016/S1470-2045(21)00302-8
