Expectations on Zejula are high

On the 10th, a meeting to commemorate the acquisition of indications for ovarian cancer primary maintenance therapy

Effective for all patient groups regardless of biomarker

“The biggest burden on recurrent ovarian cancer patients is definitely 'relapse'.

 

Zejula can play an important role for patients by preventing recurrence through primary maintenance therapy.

 

In particular, it can be used as an All-comer.

 

The appearance of Zejula is likely to make a big difference in the treatment of ovarian cancer.” Soo-Young Hur, a professor of obstetrics and gynecology at Seoul St.

 

Mary's Hospital, said at an online press conference for PARP inhibitor Zejula (Niraparib) on the 10th, about Zejula's significance of expanding the indications for primary ovarian cancer maintenance therapy.

 

Takeda Korea's ovarian cancer drug Zejula is the first PARP inhibitor that can be used regardless of whether the BRCA gene has been mutated.

 

It was approved for the first time in Korea in March 2019 as ‘a single maintenance therapy for adult patients with platinum-sensitive recurrent highly serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have fully or partially responded to platinum-based chemotherapy at least 2nd order’ Since then, the indications have been expanding.

 

In December last year, it became available for 4 or more monotherapy, and in August, it also acquired indications for first-line maintenance therapy.

 

Soo-Young Hur, a professor of obstetrics and gynecology at Seoul St.

 

Mary

This online meeting was set up to explain the clinical research and treatment significance that served as the basis for the expansion of the indications for the primary maintenance therapy of In the case of ovarian cancer, recurrence occurs within 1-3 years in most patients after chemotherapy.

 

After chemotherapy, the progression-free survival (PFS) is very short, ranging from 8 to 14 months, so maintenance therapy is selected to prolong it.

 

Maintenance therapy options include Bevacizumab, a VEGF inhibitor, and PARP inhibitors such as Olaparib , Veliparib, and Niraparib.

 

According to Professor Antonio González-Martín (The University Clinic of Navarra, Spain), the principal of PRIMA's clinical study, which was the basis for the expansion of the indications for the first-line maintenance therapy of Zejula, "The results of the PRIMA study show that the median PFS of Zejula in the HRd group is 21.9 months, and the placebo group (10.4 months).

 

Also he said.

 

"It also showed an effect in the HRp patient group." In particular, although the PRIMA study mainly included patients with high risk of recurrence, it was explained that it was effective in all patient groups regardless of biomarkers such as HRd or BRCA mutation.

 

As for the safety profile, hemologic adverse reactions were observed in some patients, but they were manageable through dose reduction or suspension of medication, he added.

 

In particular, he said about a comparative analysis with the combination therapy of Olaparib (Lynparza) + Bevacizumab (Avastin), which was approved as the first line maintenance therapy for HRd ovarian cancer patients regardless of BRCA mutation in the United States.

 

"The PAOLA study shows that the combination with Olaparib is better than Bevacizumab alone, and this only appeared in the HRd patient group." However, he commented, "It is not clear how much additional value added to Bevacizumab plus Olaparib provides." He added, “When deciding on a treatment option that is suitable for a patient, we need to consider both options, as we need to consider several factors including clinical factors.

 

There will be some patients in the group where Bevacizumab is not suitable, and also in the HRp group.

 

Zejula is the only drug that has proven its effectiveness.” Professor Hur also focused on the fact that Zejula shows effects regardless of biomarkers.

 

He said, "Olaparib can only be used when there is a BRCA mutation, but among ovarian cancer patients, the BRCA mutation is a small proportion of about 20%.

 

In addition, Bevacizumab does not require a biomarker, but it is used depending on the patient's stage, and there are concerns about side effects such as toxicity." In addition, he said, "Zejula can be used as an all-comer, and if the dose is adjusted according to individual patients, the effect can be maintained while reducing side effects." He said, "I expect that Zejula can be used as an all-commer after ovarian cancer treatment, which will bring about a huge change." And he added that the indications have recently been expanded, and due to restrictions on reimbursement, there is not much experience in prescribing Zejula as the first maintenance therapy.

 

As data accumulates in the future, it will be of great help to patients as a first-line maintenance therapy.