Hormone receptor negative HER2 positive breast cancer

Research led by the American Cancer Society finds Medicaid expansion was associated with longer survival and reduced treatment delays. PLYMOUTH MEETING, Pa., Oct. 24, 2024 /PRNewswire/ -- New research published online-ahead-of-print in JNCCN—Journal of the National Comprehensive Cancer Network found that people with newly-diagnosed hormone receptor (HR)-negative, human epidermal growth factor receptor 2 (HER2)-positive breast cancer were more likely to receive timely, guideline-concordant treatment and have longer survival in states that participate in Medicaid expansion under the Affordable Care Act (ACA). Continue Reading "Expanding Medicaid... can help ensure that more patients with cancer benefit from life-saving treatments." Post this Visit JNCCN.org to read the latest new cancer research studies. A team of researchers—led by the American Cancer Society (ACS), and including Kathryn J. Ruddy, MD, MPH, of the Mayo Clinic Comprehensive Cancer Center, a former NCCN Foundation® Young Investigator Award recipient—used data from the National Cancer Database (NCDB) to review results for women across the United States, age 18-62, who were diagnosed with this type of breast cancer between 2010 and 2018. 19,248 of the patients lived in Medicaid expansion states, while 12,153 resided in non-expansion locations. In the expansion states, the 2-year survival rate increased from the 2010 baseline rate of 93.9% to 95.0% across the study period. However, in the non-expansion states, 2-year survival declined slightly from 94.0% to 93.9%. The biggest difference was seen in patients with Stage III disease. "Expanding Medicaid to the 10 states that have yet to do so can help ensure that more patients with cancer benefit from life-saving treatments," said lead researcher Kewei Sylvia Shi, MPH, Surveillance and Health Equity Science, American Cancer Society. "It's crucial to increase access to oncology services, expand insurance coverage, and streamline diagnostic and referral processes. Stage III cancer represents a critical point in disease presentation and can further progress and become incurable if undertreated. Having health insurance coverage will make it more likely for these patients to receive timely and comprehensive access to life-saving therapies, have better medication adherence, and complete treatment, which leads to better survival outcomes." HR-negative, HER2-positive breast cancer is an aggressive subtype that accounts for approximately 5% of all breast cancer diagnoses.1 This is the first study to focus on the impact of Medicaid expansion on that specific population. The study found that treatment according to recommendations from evidence-based, expert consensus driven clinical practice guidelines—such as the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)— was more likely to begin within 90 days from diagnosis in the expansion states. "This study reinforces the important role Medicaid expansion plays in ensuring that women newly diagnosed with HR-negative, HER2-positive breast cancer have equitable access to the healthcare services they need—especially when prognosis depends on access to treatment," said Millicent Gorham, CEO of the Alliance for Women's Health and Prevention, who was not involved in this research. "Breast cancer is far too common, and rates are increasing among younger women, making it critical that policymakers also prioritize women's access to preventive health screenings and appropriate treatments." To read the entire study, visit JNCCN.org. Complimentary access to "Association of Medicaid Expansion With Timely Receipt of Treatment and Survival Among Patients With HR-Negative, HER2-Positive Breast Cancer" is now available online. The article will also be featured in the November 2024 print edition of the journal. About JNCCN—Journal of the National Comprehensive Cancer Network More than 25,000 oncologists and other cancer care professionals across the United States read JNCCN—Journal of the National Comprehensive Cancer Network. This peer-reviewed, indexed medical journal provides the latest information about innovation in translational medicine, and scientific studies related to oncology health services research, including quality care and value, bioethics, comparative and cost effectiveness, public policy, and interventional research on supportive care and survivorship. JNCCN features updates on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), review articles elaborating on guidelines recommendations, health services research, and case reports highlighting molecular insights in patient care. JNCCN is published by Harborside/BroadcastMed. Visit JNCCN.org. To inquire if you are eligible for a FREE subscription to JNCCN, visit NCCN.org/jnccn/subscribe. Follow JNCCN at x.com/JNCCN. About the National Comprehensive Cancer Network The National Comprehensive Cancer Network® ( NCCN ®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information. Media Contact: Rachel Darwin 267-622-6624 [email protected] 1 National Cancer Institute. Cancer stat facts: female breast cancer subtypes. Available at: SOURCE National Comprehensive Cancer Network WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pictured: Medicine vial over rock pile with complex data background/ Nicole Bean for BioSpace Gilead Sciences encountered a major setback in late May when its antibody-drug conjugate Trodelvy failed to reach the primary endpoint in a confirmatory Phase III trial in patients with metastatic urothelial cancer. In addition to missing the mark in overall survival, Gilead reported a higher number of deaths in the Trodelvy arm of the study. However, Wall Street analysts are still optimistic when it comes to the drug’s blockbuster potential as a future cornerstone of Gilead’s oncology franchise. TROPiCS-04 was the late-stage confirmatory trial meant to upgrade Trodelvy’s accelerated approval in previously-treated urothelial carcinoma (UC), which was granted by the FDA in 2021. The study compared Trodelvy to chemotherapy as a second-line treatment for patients with locally advanced or metastatic UC (mUC). The bottom line: the TROP2-directed antibody-drug conjugate (ADC) did not extend patients’ lives any better than chemotherapy. Hartaj Singh, managing director and senior analyst at Oppenheimer, told BioSpace that while the TROPiCS-04 results were a “bummer” and “deflating” for Gilead, there are extenuating circumstances that must be taken into consideration. Singh said the mUC trial was designed by Immunomedics, which was acquired by Gilead in 2020 for $21 billion, and that issues with the design involve some patients’ “one-off events” that may have “tilted the odds against the trial.” “I think that [Gilead] feel[s] that really nothing is altered about Trodelvy and that they’ll go to the regulators and . . . I would speculate that there’s a better than 50-50 chance the drug stays on the market for that [mUC] indication,” Singh said. Trodelvy, which is also FDA-approved for the treatment of breast cancer, earlier this year also failed a Phase III trial in non-small cell lung cancer (NSCLC), missing its overall survival endpoint. While the back-to-back losing streak for the ADC is not encouraging, there are still paths forward for Trodelvy’s expansion in oncology. From The Jaws of Defeat At the recent American Society of Clinical Oncology (ASCO) annual meeting, Gilead presented further details of the data from the EVOKE-01 NSCLC trial. The results showed that Trodelvy, when put up against the chemotherapy docetaxel, demonstrated a median overall survival of 11.1 months versus 9.8 months for docetaxel. Still, Gilead observed a more than three-month difference in median overall survival in a subgroup of patients, providing the company with the motivation to continue trialing efficacy in these patients. A Jefferies analyst note to investors acknowledged there “continues to be a debate on the next steps with Trodelvy” and that a critical factor in the future will be whether Gilead can NSCLC in the second line. “We think they will likely need to run another Phase III study, but we expect an update likely later this year after FDA discussions,” Jefferies analysts wrote. “If they are able to [second line plus] NSCLC in PD-1 refractory, we think this is all upside. Another option is they could focus their strategy on [first-line] given recent data looked good [with] 13 months [progression-free survival] for Trodelvy in PD-1 positive patients.” The Jefferies analysts also commented that the EVOKE-01 data “remains debated” among doctors as the ADC appears efficacious in PD-1 refractory NSCLC. Still, it remains unclear how the FDA will perceive Gilead’s data and whether the regulator will require a new Phase III trial to confirm efficacy. “If they are able to the subgroup analysis, this would certainly drive upside,” the analysts opined. Despite Trodelvy’s recent NSCLC stumble, some data did go Gilead’s way at ASCO. The Phase II EVOKE-02 trial, which investigated the ADC in combination with Merck’s blockbuster cancer drug Keytruda in NSCLC, showed a median PFS of 13.1 months. Gilead also touted the results as supporting “promising activity” in squamous and non-squamous populations. Jefferies analysts noted that the EVOKE-02 results had an overall response rate better than PD-1 monotherapies and better than a PD-1-chemotherapy combination. Even though Trodelvy this year has reported less-than-stellar results, Singh remains optimistic about the ADC’s future. He said he has models for the drug reaching around $1 billion annually “soon” and $2 billion within a year or two. By comparison, Trodelvy pulled in $309 million in sales in the first quarter of 2024, a 39% increase versus the same period in 2023. While there might be a “momentary downtick” in mUC sales, Singh pointed to the fact that the ADC is still a significant treatment in triple-negative and hormone receptor-positive HER2-negative breast cancer, an approval Gilead secured in early 2023. “I’m happy people are bummed out about Trodelvy because expectations have come down so low,” Singh said. “Trodelvy is growing like 20%-plus every quarter. And if that continues, which we believe it will, then people are just going to be surprised to the upside.” Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

In a Phase III trial in breast cancer patients, AstraZeneca’s Truqap plus Faslodex reduced disease progression and mortality risk. Credit: Roland Magnusson / Shutterstock.com. The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca ‘s Truqap (capivasertib) plus Faslodex (fulvestrant) for a specific type of breast cancer. The approval is for unresectable or recurrent phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha, AKT serine/threonine kinase 1 or phosphatase and tensin homolog-altered hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer. The combination is intended for adults who have progressed following endocrine therapy. Truqap is an adenosine triphosphate-competitive inhibitor while Faslodex is an endocrine therapy. The latest approval was based on data from the randomised, double-blind, global CAPItello-291 Phase III clinical trial in 708 adult patients. See Also: EC approves Bristol Myers Squibb’s Reblozyl for first-line MDS treatment China accepts Innovent-HUTCHMED’s endometrial cancer therapy NDA This trial assessed the efficacy of Truqap plus Faslodex compared to placebo plus Faslodex. Progression-free survival in the overall trial population and subjects with PI3K/AKT pathway alterations were the trial’s dual primary endpoints. Results from the trial showed that Truqap plus Faslodex halved disease progression and mortality risk. The safety profile of the combination regimen was consistent with previous studies. Truqap’s discovery by AstraZeneca followed a partnership with Astex Therapeutics, which now stands to receive milestone payments and royalties from product sales in Japan. Regulatory reviews are ongoing in regions, including China and the European Union, with the combination already approved in the US and other countries. AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “Breast cancer is the most common cancer among women in Japan, and innovative new treatment options are urgently needed. “The approval of Truqap, a first-in-class AKT-inhibitor, represents a significant step forward for HR-positive breast cancer treatment and an important new option for approximately 50% of patients who have tumours with these specific mutations or alterations.” The MHLW has also approved AstraZeneca and Sanofi ‘s Beyfortus, a long-acting monoclonal antibody for the prevention and prophylaxis of respiratory syncytial virus-linked lower respiratory tract disease in neonates, infants and children. The latest development comes after AstraZeneca agreed to acquire Fusion Pharmaceuticals for $2.4bn to broaden its portfolio of radioconjugates .