Efficacy

Zejula (Niraparib) Efficacy in Gynecological Cancer

Zejula (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor used for the treatment of certain gynecological cancers, including ovarian, fallopian tube, and primary peritoneal cancers. It is particularly effective in patients who have a somatic or germline BRCA mutation. Clinical trials have demonstrated that niraparib significantly improves progression-free survival (PFS) in patients with recurrent ovarian cancer. In the NOVA trial, a pivotal Phase 3 study, niraparib substantially extended PFS in patients with recurrent ovarian cancer who were in response to platinum-based chemotherapy, regardless of BRCA mutation status. However, the greatest benefit was observed in patients with a BRCA mutation.

For maintenance therapy, niraparib is approved for use in the first-line setting after a response to platinum-based chemotherapy. The PRIMA study showed that niraparib significantly improved PFS compared to placebo in a broad population of patients with newly diagnosed advanced ovarian cancer following a response to first-line platinum-based chemotherapy, including those with homologous recombination deficiency (HRD) positive and HRD-negative tumors. This suggests that niraparib may offer a robust maintenance therapy option for a wide range of patients with advanced ovarian cancer.

Jemperli (Dostarlimab) Efficacy in Gynecological Cancer

Jemperli (dostarlimab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen and is mismatch repair deficient (dMMR), which is a type of gynecological cancer. The efficacy of dostarlimab was evaluated in the GARNET trial, a multi-cohort, multicenter, non-randomized, open-label trial. In this trial, dostarlimab demonstrated a meaningful objective response rate (ORR) in patients with dMMR recurrent or advanced endometrial cancer, with a significant proportion of patients achieving complete or partial response.

Furthermore, the duration of response (DOR) with dostarlimab in the GARNET trial was notable, with many patients maintaining their response for six months or longer. This indicates that dostarlimab can provide durable responses in a subset of patients with advanced endometrial cancer that is dMMR. It is important to note that the approval of dostarlimab for this indication is under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.