KEY TAKEAWAYS
- The phase 3 RUBY study evaluated the safety of dostarlimab with carboplatin/paclitaxel for patients with primary advanced or recurrent endometrial cancer.
- The study suggested that the safety of combining dostarlimab with carboplatin/paclitaxel aligned with their individual safety profiles.
In the third phase of the RUBY trial, patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) showed a marked improvement in PFS when treated with a combination of dostarlimab and carboplatin/paclitaxel compared to just carboplatin/paclitaxel. This improvement was especially evident in patients with mismatch repair deficiencies/microsatellite instability-high (HR 0.28) and the general population studied (HR 0.64). There was also a positive trend in overall survival (HR 0.64). Researchers have reported the safety of the RUBY trial.
Patients with pA/rEC were evenly divided to receive either dostarlimab 500 mg or a placebo, along with carboplatin AUC 5 and paclitaxel 175 mg/m2 every three weeks for six cycles. This was followed by either dostarlimab 1000 mg or a placebo every six weeks for a maximum of three years. The adverse effects were evaluated based on the CTCAE v4.03 criteria.
Of the 487 pts in the safety study, each received at least one treatment dose (241 received dostarlimab+carboplatin/paclitaxel; 246 received placebo+carboplatin/paclitaxel). All pts experienced treatment-emergent side effects. 70.5% of those in the dostarlimab group and 59.8% in the placebo group faced side effects of grade ≥3. The median onset for these side effects was 2.0 days for the dostarlimab group and 2.5 days for the placebo group.
Treatment-related side effects caused 23.7% of the dostarlimab group and 16.7% of the placebo group to stop treatment. More pts stopped treatment during the initial chemotherapy cycles (1-6) compared to the later cycles. 17.4% and 9.3% of patients stopped taking dostarlimab or placebo, respectively, due to side effects.
Discontinuation rates for carboplatin or paclitaxel were similar in both groups. 38.2% of those on dostarlimab and 15.4% on placebo reported immune-related side effects. In the dostarlimab group, there were five deaths, with two being attributed to the drug.
The study demonstrated that the combined use of dostarlimab and carboplatin/paclitaxel had a safety profile similar to their individual usage. Adding dostarlimab didn’t affect the completion rate of chemotherapy. Given its benefits and risks, the combination of dostarlimab and carboplatin/paclitaxel emerges as a promising therapeutic option for pA/rEC pts.
Source: https://www.emma.events/site/programme/?sessiondetail=4534534&trackid=0&a=esgo2023#!
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03981796
Auranen, A., Black, D., Sukhin, V., Sharma, S., Ronzino, G., Landrum, L.M., Bauerschlag, D., Willmott, L., Lalisang, R., Buscema, J., Gilbert, L., Coleman, R.L., Bender, D., Armstrong, A., Nevadunsky, N., Powell, M.A., Dabrowski, C., Stevens, S., Mirza, M.R., Fleming, E. Safety Of Dostarlimab In Combination With Chemotherapy In Patients With Primary Advanced Or Recurrent Endometrial Cancer In A Phase 3, Randomized, Placebo-Controlled Trial (ENGOT-EN6-NSGO/GOG-3031/RUBY).
