Olaparib

The annual San Antonio Breast Cancer Symposium was held from Dec. 10 to 13 in San Antonio. Attendees included medical oncologists, radiation oncologists, researchers, and other health care professionals. The conference highlighted recent advances in the risk, diagnosis, treatment, and prevention of breast cancer, and presentations focused on emerging treatments in hard-to-treat patient populations, including patients with metastatic breast cancer. As part of the BIG 2-04 MRC SUPREMO phase 3 clinical trial, Ian Kunkler, M.B., B.Chir., of the University of Edinburgh in the United Kingdom, and colleagues found that chest wall irradiation may be omitted among patients with intermediate-risk breast cancer who have undergone mastectomy. For the study, patients were randomly assigned to receive chest wall irradiation after mastectomy or to omit chest wall irradiation after mastectomy. The researchers found that postmastectomy radiotherapy to the chest wall among women with one to three positive axillary nodes after an axillary clearance or negative on an axillary clearance, axillary node sample, or sentinel node biopsy was not associated with an improvement in 10-year overall survival. The investigators also found that postmastectomy radiotherapy reduced chest wall recurrence by less than 2 percent at 10 years. Furthermore, the approach did not have an impact on metastasis-free survival. "Postmastectomy radiotherapy National Institute for Health and Care Excellence guidelines currently recommend radiotherapy in women with one to three positive nodes after mastectomy," Kunkler said. "So, our results should change guidelines and practice internationally." Press Release As part of the phase 3 COMET study, Ann Partridge, M.D., M.P.H., of the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues found that active monitoring is a reasonable approach for the management of patients with grade 1 or 2, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative low-risk ductal carcinoma in situ (DCIS), with no evidence of a higher incidence of microinvasive or invasive disease. For the study, patients were randomly assigned to either undergo active monitoring or receive guideline-concordant care consisting of surgery with or without adjuvant radiation. During a two-year period, the authors assessed quality of life, anxiety, depression, worries about DCIS, and symptom trajectories via surveys that employed validated quality-of-life measures. Patients filled out surveys prior to randomization, at six months, at one year, and after two years. The researchers found that the overall lived experience of women randomly assigned to active monitoring was similar to that of those selected to follow the current guideline for care, which is surgery with or without radiation. During the two years of follow-up, health-related quality of life, anxiety, depression, worry, and symptom trajectories were comparable regardless of the treatment received. "If longer-term follow-up supports the safety of active management from a cancer outcome standpoint, this approach could be considered as an option for women with this condition," Partridge said. "It is critical that we understand how women feel when they are living with an active-monitoring approach and how it impacts their overall quality of life, psychosocial health, worries about DCIS, anxiety and depression, and other related symptoms. These data are reassuring in that respect." Press Release In the multicenter, double-blind OlympiA study, Judy E. Garber, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues provided further support for the benefits of olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, among patients with high-risk, HER2-negative breast cancer with germline mutations in BRCA1 or BRCA2 . The authors randomly assigned 1,836 patients with BRCA -positive, HER2-negative breast cancer (1:1) to receive either olaparib or placebo for one year following completion of chemotherapy, surgery, and radiation. The researchers found that after a median follow-up of 6.1 years, patients with high-risk, BRCA -positive breast cancer who received olaparib after standard treatment continued to have better survival outcomes than those who received placebo. The continued demonstration of the efficacy of olaparib in breast cancer patients who carry pathogenic variants in BRCA1/2 makes it important to identify these individuals when they begin their treatment, the authors noted. "The ongoing data from the OlympiA trial are reassuring in the observations of persistent and increasing benefits in the follow-up phases, improving not only recurrence, but also overall survival. Benefits are demonstrated in both triple-negative breast cancer as well as hormone receptor-positive tumors, despite the shortened follow-up and smaller numbers in the estrogen receptor-positive group," Garber said. "These data also highlight the safety of olaparib and, therefore, the possibility of moving PARP inhibitors to the treatment of BRCA -associated breast cancers that are lower risk." The study was supported by AstraZeneca and Merck, the manufacturers of olaparib. Press Release SABCS: Chest Wall Irradiation Does Not Impact Survival in Breast Cancer MONDAY, Dec. 16, 2024 -- For patients with intermediate-risk breast cancer, chest wall irradiation after mastectomy does not influence 10-year overall survival, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Risk-Reducing Surgery Improves Outcomes in Young Breast Cancer Patients With BRCA Mutations MONDAY, Dec. 16, 2024 -- Risk-reducing mastectomy and salpingo-oophorectomy are both associated with significant improvements in outcomes among young BRCA carriers with breast cancer, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Adding Camrelizumab to Neoadjuvant Chemo Beneficial in TNBC FRIDAY, Dec. 13, 2024 -- The addition of camrelizumab to neoadjuvant chemotherapy improves pathological complete response for patients with early or locally advanced triple-negative breast cancer, according to a study published online Dec. 13 in the Journal of the American Medical Association to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Active Monitoring Noninferior to Guideline Care for Ductal Carcinoma in Situ FRIDAY, Dec. 13, 2024 -- For patients with ductal carcinoma in situ, active monitoring is noninferior to guideline-concordant care that involves surgery with or without adjuvant radiation, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Omission of Axillary Staging Noninferior for Node-Negative Breast Cancer FRIDAY, Dec. 13, 2024 -- Omission of surgical axillary staging is noninferior to sentinel lymph-node biopsy for patients with clinically node-negative, T1 or T2 invasive breast cancer, according to a study published online Dec. 12 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text SABCS: Imlunestrant Tied to Improved PFS for ER-Positive, HER2-Negative Breast Cancer With ESR1 Mutations THURSDAY, Dec. 12, 2024 -- For patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer, imlunestrant leads to significantly longer progression-free survival among those with ESR1 mutations, according to a study published online Dec. 11 in the New England Journal of Medicine to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 10 to 13 in San Antonio. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Merck & Co – known as MSD outside of the US and Canada – has shared positive results from a late-stage trial of a Keytruda (pembrolizumab)/Lynparza (olaparib) regimen as a first-line treatment for advanced ovarian cancer. The phase 3 KEYLYNK-001 trial has been evaluating Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy followed by maintenance with the company’s AstraZeneca-partnered PARP inhibitor Lynparza, with or without bevacizumab, in patients with advanced epithelial ovarian cancer without BRCA mutations. The study met its primary endpoint, with the Keytruda/Lynparza regimen demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone. The study did not reach its secondary endpoint of overall survival, however, with Merck noting that the role of Keytruda in the intention-to-treat population “remains uncertain at this time”. Ovarian cancer, which usually begins in the fallopian tubes or on the outer surface of the ovaries, is the second most common gynaecological malignancy and seventh most common cancer in women globally. Approximately 19,680 cases of the disease are expected to have been diagnosed in the US by the end of 2024. Keytruda is designed to increase the ability of the body’s immune system to help detect and fight tumour cells, while Lynparza prevents the DNA of cancer cells from being repaired, preventing them from growing and spreading. Keytruda already holds approvals to treat a wide range of cancers, including specific cases of breast, cervical and bladder cancer, but is not approved for use in ovarian cancer. Lynparza, however, has three approved indications in ovarian cancer in the US. Merck said the results from KEYLYNK-001 will be presented at an upcoming medical meeting and discussed with regulatory authorities. “For people living with ovarian cancer, there remains an unmet need for new treatment options that have the potential to improve outcomes,” said Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, adding that KEYLYNK-001 is the first positive phase 3 trial for Keytruda plus Lynparza. The results come two months after Merck shared positive results from the phase 3 KEYNOTE-689 trial of Keytruda as a perioperative treatment for patients newly diagnosed with stage 3 or 4A, resected, locally advanced head and neck squamous cell carcinoma.