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Gulf Today
a day ago
- Health
- Gulf Today
New breast cancer therapy can slow advance of disease, prolong survival
A new triple therapy for aggressive, advanced breast cancer slows the progression of the disease, delays the need for further chemotherapy and helps patients live longer, research revealed. The combination treatment is made up of two targeted drugs: inavolisib and palbociclib, and the hormone therapy fulvestrant. It improved overall survival by an average of seven months, compared with the patients in the control group, who were given palbociclib and fulvestrant. It also delayed progression of the disease by 17.2 months, on average, compared with 7.3 months in the control group, and patients taking inavolisib were able to delay subsequent chemotherapy treatment by almost two years longer than the patients in the control group. The results of the study, funded by Roche, were presented at the American Society of Clinical Oncology (Asco) annual meeting in Chicago and published in the New England Journal of Medicine. The international trial involved 325 patients from 28 countries, including the US, UK, Australia, Singapore, Brazil, France and Germany. Experts said it demonstrated the potential of the triple therapy for targeting PIK3CA-mutated HR+, HER2- breast cancer - a common form of the disease. About 70 percent of patients have HR+, HER2- breast cancer. PIK3CA mutations are found in 35 to 40 percent of HR+ breast cancers, and are linked to tumour growth, disease progression and treatment resistance. "The INAVO120 trial has identified a targeted treatment regimen that meaningfully improves survival in patients with untreated PIK3CA-mutated hormone receptor-positive metastatic breast cancer - a big step forward for these patients,' said Dr Jane Lowe Meisel, Co-Director of Breast Medical Oncology at Winship Cancer Institute of Emory University, and an Asco expert in breast cancer. The results also showed a substantial shrinking in cancer growth in about 62.7 percent of patients in the triple therapy group compared with 28 percent in the control group. Dr. Simon Vincent, Director of Research, support and influencing at Breast Cancer Now, said the findings were a "significant breakthrough'. Dr. Nisharnthi Duggan, a research information manager at Cancer Research UK, said, "The trial showed that adding inavolisib to targeted treatment plans improved survival. On top of this, it also delayed the progression of people's cancer and the need for chemotherapy, which could improve quality of life. We hope that more research like this will help to give people kinder cancer treatment options, and more time with their loved ones.' In the trial, more than half of the patients had disease that had already spread to three or more organs. The researchers used circulating tumour DNA (ctDNA) liquid biopsy blood tests to determine whether patients had a PIK3CA mutation. Participants were then allocated to receive either the inavolisib-based regimen or a combination of palbociclib, fulvestrant and a dummy pill. The new drug inavolisib works by blocking the activity of the PIK3CA protein. The inavolisib combination was generally well tolerated with only a few patients experiencing side-effects that led them to discontinue the treatment. Nick Turner, Professor of Molecular Oncology at the Institute of Cancer Research, London, and consultant medical oncologist at the Royal Marsden NHS Foundation Trust, led a UK arm of the trial. "The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible," he stated. WAM
New York Post
3 days ago
- Health
- New York Post
Breast cancer risk cut by 35% in new clinical trial
Trodelvy in combination with Merck's blockbuster immunotherapy Keytruda lowered the risk of an aggressive type of breast cancer worsening by 35% when used as an initial treatment, according to results of a large trial presented on Saturday. The data is likely to change how patients are treated following a diagnosis for advanced triple-negative breast cancer, one expert said. After a median follow-up of 14 months, patients treated with Trodelvy, a so-called antibody-drug conjugate, and Keytruda went 11.2 months without their cancer progressing, a measure known as progress-free survival. That compared with PFS of 7.8 months for those given the standard treatment of chemotherapy and Keytruda, researchers said. Advertisement 3 Trodelvy, in combination with Merck's immunotherapy Keytruda, lowered the risk of an aggressive type of breast cancer worsening by 35% when used as an initial treatment, according to new results. REUTERS Patients given the Trodelvy/Keytruda combination responded to the treatment for a median of 16.5 months, compared with 9.2 months for the chemo group, according to full results of the study presented at the American Society of Clinical Oncology scientific meeting in Chicago. The researchers said patients are still being followed to see if the regimen has an impact on overall survival. Gilead previously said the Phase 3 study in 443 patients with advanced triple-negative breast cancer whose tumors express PD-L1 – the protein targeted by drugs like Keytruda – had met its goal. Advertisement The findings suggest that the combination of Trodelvy and Keytruda 'will likely become a new front-line standard of care in this setting,' Dr. Jane Lowe Meisel, co-director of breast oncology at Emory University School of Medicine and a designated ASCO expert, said in a statement. ASCO estimates that about 10% of breast cancers in the United States are triple-negative. 3 Patients given the Trodelvy/Keytruda combination responded to the treatment for a median of 16.5 months, compared with 9.2 months for the chemo group, according to the results. Peakstock – That tends to be more difficult to treat than hormone-sensitive subtypes, because it does not have the common biomarkers used to guide treatment, the tumors are often larger, and the recurrence rate is high. Advertisement The medical group said that about 40% of triple-negative breast cancers are also PD-L1 positive, making them candidates for Keytruda. Antibody-drug conjugates like Trodelvy are designed to deliver an anti-cancer drug more precisely to malignant cells, causing less damage to healthy cells than chemotherapy. 3 Gilead is also conducting several other Trodelvy studies, including a trial of the drug as an initial treatment for triple-negative breast cancer patients who do not express PD-L1. REUTERS Serious side effects for Trodelvy included neutropenia, a condition caused by cancer treatments that lower levels of infection-fighting white blood cells, reported in 43% of patients, and diarrhea in 10%. In the chemotherapy group, the incidence of neutropenia was 45%, while 16% of patients had anemia and 14% had low blood platelet counts. Advertisement Trodelvy is already approved for patients with advanced triple-negative breast cancer who had two or more prior therapies, and for previously treated hormone-receptor-positive, HER2-negative metastatic breast cancer. Gilead is conducting several other Trodelvy studies, including a trial of the drug as an initial treatment for triple-negative breast cancer patients who do not express PD-L1.
Yahoo
3 days ago
- Business
- Yahoo
Full Arvinas, Pfizer data confirm potential and limits of ‘Protac' drug in breast cancer
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. An experimental breast cancer drug from Arvinas and partner Pfizer modestly slowed disease progression in people whose tumors had changes to a specific gene, but did not provide a clear benefit to others who lacked that mutation. Full study results set to be presented Saturday at the American Society of Clinical Oncology's annual meeting provide a clearer picture of the drug's potential — and its limitations — than were available in March, when the companies shared an overview of trial outcomes. While the findings suggest the drug, an oral pill called vepdegestrant, may be a new option for a subset of breast cancer patients, they likely mean its use will remain narrow, should it win an approval. In their Phase 3 trial, Arvinas and Pfizer tested vepdegestrant against the injectable drug fulvestrant in 624 people who had the most common type of advanced breast cancer — tumors positive for estrogen receptors but negative for a protein called HER2. Trial participants had been treated before with hormone therapy and another type of drug known as a CDK4/6 inhibitor. Two-hundred and seventy participants had mutations in the ESR1 gene, which is known to help tumors develop resistance to treatment. The detailed data unveiled Saturday show vepdegestrant extended progression-free survival in people with ESR1 mutations by a median of five months, compared to 2.1 months for those on fulvestrant. Among study participants overall, however, median progression-free survival was similar: 3.8 months on vepdegestrant versus 3.6 months on fulvestrant. PFS measures the time from a treatment response to when either disease progression or death. Speaking in a briefing with reporters ahead of ASCO, Jane Lowe Meisel, co-director of breast medical oncology at the Winship Cancer Institute of Emory University School of Medicine, described vepdegestrant as an 'exciting option.' Yet she noted in a statement how 'on average, patients did not have prolonged responses on either agent, highlighting the need for combination therapies and continued development in this space.' Fulvestrant, the drug Arvinas and Pfizer tested vepdegestrant against, is a common treatment for advanced breast cancers that are hormone receptor positive and HER2 negative. The drug, which has been on the market for over two decades, blocks growth signaling to tumors through those hormone receptors. But the therapy has drawbacks, such as monthly intramuscular injections and a range of side effects. Vepdegestrant works differently. The oral drug is what's known as a proteolysis-targeting chimera, or PROTAC. It is designed to break down estrogen receptors, thereby cutting off the signals that promote tumor growth. To date, vepdegestrant is the first PROTAC to advance through Phase 3 testing, and the first of its type to tested in people with advanced breast cancer. Study researchers also measured overall survival but data on that score remain 'immature.' Essentially, too few people have died in the trial to draw conclusions about the statistical differences between the vepdegestrant and fulvestrant groups. Side effects for both treatments were common. Just over one-fifth of participants taking vepdegestrant experienced side effects that were rated severe or life-threatening, compared to 17.6% on fulvestrant. More participants on vepdegestrant — 2.9% — stopped treatment due to side effects at 2.9%, compared to 0.7% among those on fulvestrant. While vepdegestrant held no apparent benefit among the overall population, the drug could still hold promise for breast cancer patients with the ESR1 mutation. Such a role would be valuable as treating ESR1-mutated breast cancer remains challenging. Research led by Memorial Sloan Kettering Cancer Center researchers a decade ago found ESR1 mutations change the shape of the estrogen receptor in such a way that keeps pushing the cancer to grow, even in the absence of an estrogen signal. ESR1 mutations are estimated occur in approximately 40% to 50% of patients who undergo first-line therapy for metastatic breast cancer. Testing for the mutation is now done regularly, but typically occurs only after cancer has progressed or returned. It's become more prevalent since the approval of Orserdu, which is cleared for use in people with ER-positive, HER2-negative breast cancer that is positive for ESR1 mutations. Pfizer and Arvinas in March said they will share data from their study with health regulators in support of potential drug approval applications. But since then, the companies have scaled back their development of vepdegestrant, removing plans for two other Phase 3 trials. Arvinas also cut one-third of its staff. Recommended Reading Arvinas gets positive breast cancer data, but finds differentiation a hard sell
