LYNPARZA Trial for BRCA-Mutated HER2-Negative Breast Cancer Achieved iDFS Superiority Boundary

 

In a joint statement, biopharmaceutical companies AstraZeneca and Merck & Co., Inc. (“Merck”) shared that LYNPARZA (olaparib) achieved a superiority boundary in the Phase 3 OlympiA clinical trial. During the trial, researchers evaluated LYNPARZA for patients with germline BRCA-mutated HER2-negative breast cancer. When compared to a placebo, LYNPARZA offered a significantly more beneficial impact and helped patients survive longer without cancer progression. Now, the Independent Data Monitoring Committee (IDMC) has suggested that the clinical trial will continue on to early reporting and primary analysis.

LYNPARZA

Also known as olaparib, LYNPARZA is a PARP inhibitor developed by AstraZeneca and Merck. According to the National Cancer Institute (NCI), PARP inhibitors:

[block] an enzyme in cells called PARP, [which] helps repair DNA when it becomes damaged. DNA damage may be caused by many things, including exposure to UV light, radiation, certain anticancer drugs, or other substances in the environment.

In cancer treatments, such as LYNPARZA, the drug works by preventing cancer cells from repairing broken or damaged DNA. LYNPARZA is specifically targeted to attack cells with HRR deficiencies; these are usually found in BRCA mutations. So far, over 40,000 patients globally received LYNPARZA.

Outside of breast cancer, LYNPARZA is also indicated as a treatment option for patients with:

  •  BRCA-mutated ovarian cancer
  • Ovarian cancer
    • Researchers are looking at whether LYNPARZA can treat ovarian cancer alone or in conjunction with other treatments, such as bevacizumab.
  • BRCA-mutated metastatic pancreatic adenocarcinoma
  • HRR-mutated metastatic castration-resistant prostate cancer

The OlympiA Trial

Altogether, the Breast International Group (BIG), Merck, AstraZeneca, NRG Oncology, the NCI, and the Frontier Science & Technology Research Foundation (FSTRF) collaborated to run the Phase 3 OlympiA clinical trial. Within this double-blind trial, researchers evaluated the safety, efficacy, and tolerability of LYNPARZA. The therapy is orally administered. In particular, researchers sought to understand whether the treatment is more effective as an adjuvant therapy following localized treatment and chemotherapy. Adjuvant is defined as something which is administered after an initial cancer treatment.

Ultimately, the drug was found to be relatively safe and well-tolerated. It also assisted in improving invasive progression-free survival rates. Currently, LYNPARZA is only approved for use in adult patients and has not been tested in pediatric patients.

Although the drug is relatively safe, some adverse reactions did occur. These adverse reactions spanned the OlympiA trial, as well as other clinical trials evaluating LYNPARZA for other cancers. Adverse reactions across all clinical trials include:

  • Diarrhea or constipation
  • Nausea and vomiting
  • Changes in taste
  • Fatigue
  • Anemia (low red blood cell count)
  • Neutropenia (low white blood cell count)
  • Leukopenia (low leukocyte count)
  • Thrombocytopenia (low platelet count)
  • Stomatitis (inflammation of the mouth and lips)
  • Shortness of breath
  • Indigestion
  • Abdominal and muscle pain
  • Dizziness
  • Appetite loss
  • Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)
  • Pneumonitis
  • Pulmonary embolism and venous thrombosis
  • Urinary tract or upper respiratory tract infections

Breast Cancer

Breast cancer is a type of cancer which forms in breast cells. Although it can affect both males and females, it is the 2nd most common cancer in females. BRCA1 and BRCA2 gene mutations cause around 10% of diagnoses. Other risk factors include obesity, never having been pregnant, alcohol use, age, and a family history of breast cancer. Up to 65% of people with BRCA1 gene mutations, and 45% with BRCA2 mutations, will have breast cancer before they turn 70. Typically, BRCA1 mutations are associated with triple-negative breast cancer, while BRCA2 mutations are associated with post-menopausal breast cancer. BRCA mutations also increase the risk of developing colon, prostate, pancreatic, and ovarian cancer. Learn more about BRCA-mutated breast cancer here.

In early stages of breast cancer, patients may be asymptomatic. However, as the cancer progresses, symptoms could include:

  • Skin irritation or dimpling
  • Breast inflammation
  • A lump in the breast tissue
  • Inverted nipples
  • Changes in breast size, shape, or appearance
  • Nipple discharge
  • Crusty, scaly, flaky, or peeling breast or nipple skin

Learn more about breast cancer here.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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