How Lynparza works
During the normal aging process, cells accumulate damage in their genetic material (DNA) and eventually die. Tumor cells, however, evade death and are able to trigger cell proliferation by using a multiway mechanism to repair the damaged DNA. Enzymes called poly ADP-ribose polymerases (PARP) aid the DNA repair mechanism.
Cancer cells with a mutation in the BRCA gene are deficient in some elements of the DNA repair mechanism and rely on PARP to stay alive.
Lynparza prevents the action of the PARP enzymes, which — combined with the deficiencies in the DNA repair mechanism of BRCA-mutated cells — kills tumor cells caused by excessive accumulation of damage to DNA.
Lynparza in clinical trials
A Phase 3 placebo-controlled study (NCT02000622) to compare the safety and effectiveness of Lynparza to that of standard chemotherapy for the treatment of metastatic breast cancer patients with germline BRCA1/2 mutations is currently ongoing.
The results so far have shown that Lynparza reduces the risk of cancer growth by up to 42 percent compared to standard chemotherapy. In addition, in 60 percent of patients treated with Lynparza, the tumor showed evident shrinkage; similar shrinkage was registered in only 29 percent of women on standard chemo. For women on standard chemo, disease progression occurred within 4.2 months, while in women treated with Lynparza, it took seven months for the disease to progress.
Lynparza also showed fewer side effects compared to standard chemo. Only 5 percent of patients discontinued treatment in the Lynparza arm, compared to 8 percent in the chemotherapy arm.
Two clinical trials are now recruiting breast cancer patients to further test Lynparza. One is a placebo-controlled Phase 3 study called OlympiAD (NCT02032823), which is assessing the safety and effectiveness of Lynparza as an adjuvant treatment in women with germline BRCA1/2 mutations who have completed definitive local treatment and neoadjuvant or adjuvant chemo. The trial expects to enroll up to 1,500 patients.
The second trial, called PARTNER (NCT03150576), is a randomized Phase 2/3 study evaluating the safety and efficacy of the addition of Lynparza to platinum-based neoadjuvant chemotherapy in 527 breast cancer patients with germline BRCA-mutations.
The most common adverse reactions to Lynparza are anemia, nausea, fatigue, vomiting, diarrhea, loss of sense of taste, indigestion, headache, decreased appetite, cough, rash, and pain in the muscles, bones, back and abdomen.
Lynparza is the first and only PARP inhibitor approved to treat metastatic breast cancer. The FDA has approved it as monotherapy in patients with germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The drug is also approved by the European Medicines Agency (EMA) as a monotherapy to treat patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who respond to platinum-based chemotherapy.
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