Efficacy

Rubraca (rucaparib) Efficacy in Gynecological Cancer

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor that has shown efficacy in the treatment of certain types of gynecological cancers, specifically ovarian cancer. It is approved for the treatment of advanced ovarian cancer in patients who have been treated with two or more chemotherapies and whose tumors have a specific genetic marker, known as a deleterious BRCA mutation (either germline or somatic). Clinical trials have demonstrated that rucaparib significantly improves progression-free survival compared to placebo in patients with recurrent ovarian cancer who have a BRCA mutation.

In the ARIEL3 clinical trial, rucaparib was shown to be effective as a maintenance treatment for women with platinum-sensitive recurrent ovarian cancer. The trial found that rucaparib significantly extended progression-free survival compared to placebo in all three populations studied: those with BRCA mutations, those with homologous recombination deficiency-positive tumors, and the overall trial population. This suggests that rucaparib can be beneficial for a broader group of patients beyond those with BRCA mutations, although the greatest benefit was observed in the BRCA-mutated cohort.

Tivdak (tisotumab vedotin-tftv) Efficacy in Gynecological Cancer

Tivdak (tisotumab vedotin-tftv) is an antibody-drug conjugate that targets tissue factor, which is frequently overexpressed in various types of cancer, including gynecological cancers. It was granted accelerated approval by the FDA for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The efficacy of Tivdak was evaluated in the innovaTV 204 trial, a single-arm, multicenter study of patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens.

The trial demonstrated that Tivdak achieved a notable overall response rate, with a certain percentage of patients experiencing partial or complete responses. The duration of response was also significant, with many patients maintaining their response for six months or longer. These results indicate that Tivdak can provide a clinically meaningful benefit for patients with previously treated recurrent or metastatic cervical cancer. However, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.