BeiGene has just announced that China has given conditional approval to Pamiparib, a PARP inhibitor used as a therapy for BRCA associated ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This therapy is specifically indicated for patients who have already received treatment with two or more forms of chemotherapy.
Approval of this therapy will depend on the results of trials which are still ongoing.
This therapy inhibits PARP1 and PARP2. It has also demonstrated its ability to penetrate the brain and trap the PARP-DNA complex. It is currently being studied for an array of solid tumor cancers both as a therapy on its own, and as a combination treatment.
It has been uniquely designed to sustain response against the tumor as well as to reduce drug resistance. The therapy is taken twice daily orally at a 60mg. So far, it has been very well tolerated.
Across all indications of the therapy, 1,200 patients are enrolled in trials.
Clinical trials of pamiparib include:
- Phase 3 – (NCT03519230)
- Phase 2 – (NCT03712930)
- Phase 2 – (NCT03575065)
- Phase 2 – (NCT03427814)
- Phase 1/2 – (NCT03333915)
- Phase 1b/2 – (NCT03150862)
- Phase 1b – (NCT03150810)
- Phase 1b -(NCT02660034)
Its most current trial is a Phase 3 investigation evaluating the therapy for those with platinum-sensitive recurrent ovarian cancer.
The Conditional Approval
Since recurrence of disease is so common with patients who are diagnosed with advanced ovarian cancer, as well as the high toxicity of traditional chemotherapy, Pamiparib could be an advantageous option.
This milestone for this therapy for those with fallopian tube cancer, ovarian cancer, and primary peritoneal cancer is thanks to the Phase 2 component of a Phase 1/2 trail. This trial can be found on Clinicaltrials.gov by searching NCT03333915.
In this trial, 113 patients were enrolled who had different forms of cancer, had the gBRCA gene mutations, and who had undergone two forms of chemotherapy.
In the efficacy analysis, at a follow-up of 17 months, the response rate for patients with platinum-sensitive ovarian cancer was 68.3%. The median response duration was 13.8 months. For those with platinum-resistant cancer, the median follow-up was 11.6 months. The response rate was 31.6% and the median duration of response was 11.1 months.
The safety of this therapy has been documented as positive with minimal adverse events including nausea, vomiting, anemia, and fatigue.
You can read more about this therapy and its conditional approval in China here.