Jonsson Comprehensive Cancer Center

On September 17, 2024, Novartis announced that its CDK4/6 inhibitor Kisqali (Libocik) has been approved by the U.S. Food and Drug Administration (FDA) for early stage breast cancer (EBC) as adjunctive therapy for patients with HPRT+/HER2- early stage breast cancer. This approval will almost double the likelihood that eligible patients will be able to use Kisqali when receiving adjuvant therapy. The approval is based on results from the pivotal Phase III NATALEE trial, which showed a significant reduction in the risk of disease recurrence in a broad range of HR+/ HER2-stage II and III EBC patients, including those with high-risk N0 disease (3-6), receiving adjuvant Kisqali plus endocrine therapy (ET). The benefit of invasive disease-free survival (iDFS) compared to receiving endocrine therapy (ET) alone was consistently observed in all patient subgroups 3-6. "The FDA's approval of Kisqali for people with early breast cancer, including those without the disease, is a critical moment in improving our approach to care." Dennis J. Slamon, M.D., director of clinical/Translational research at UCLA Jonsson Comprehensive Cancer Center, chair of the Council on Translational Cancer Research (TRIO) and principal investigator of the NATALEE trial. "Today's approval allows us to offer CDK4/6 inhibitor therapy to a broader population as a powerful tool that, in combination with endocrine therapy, can help further reduce the risk of cancer recurrence." In EBC, Kisqali is taken orally once a day at a dose of 400 mg (two 200 mg tablets) for three weeks with or without food, followed by a week of discontinuation of treatment and four weeks in combination with any AI1. Patients should take Kisigali for three years. The NATALEE trial showed that Kisqali's 400mg dose was well tolerated, with discontinuation mainly due to asymptomatic laboratory results3. Adverse events (aes) of particular concern in the Kisqali + ET group in the NATALEE trial included (all grades and grades 3/4): neutropenia (62.5%, 44.3%), liver-related aes (26.4%, 8.6%), QT interval prolongation (5.3%, 1.0%) and interstitial lung disease/pneumonia (1.5%, 0.0%)4. The latest analysis of the NATALEE trial, recently presented at the European Society of Medical Oncology (ESMO) 2024 Congress, strengthens the data analyzed by the FDA. The results showed that after three years of treatment, the benefit was deepened and the risk of recurrence was reduced by 28.5% (HR=0.715; Ci 95% 0.609-0.840; P<0.0001), compared to ET alone, in stage II and III HR+/ HER2-EBC7 patients. Novartis will continue to evaluate the long-term prognosis of patients with NATALEE, including overall survival. In the United States, approximately 90% of breast cancer cases are diagnosed early (stage I-III) and treated promptly with the aim of a cure - sometimes with adjuvant therapy. Despite this, stage II and III HR+/ HER2-EBC patients are still at risk of their cancer coming back - in most cases, as incurable metastatic disease, 8,9. Although most tumors recur in the first few years, even in cases where no lymph nodes are involved, recurrence remains a lifelong problem. Despite ET, 10% of patients with high-risk N0 disease may face relapse within the first three years after diagnosis. Victor Bulto, president of Novartis USA, said: "With this approval, we are redefining treatment options for a broader population affected by breast cancer and at risk of ongoing recurrence. "We continue to transform cancer treatment with Kisqali, building on its established profile in metastatic Settings and now helping a wide range of people as they struggle to remain cancer-free after an early diagnosis." In the pivotal Phase II NATALEE clinical trial, Kisqali showed a significant 25% reduction in the risk of recurrence compared to patients who received endocrine therapy (ET) alone. The trial results showed consistent efficacy across all patient subgroups and had a good safety profile, including in node-negative patients. At the recently concluded European Society of Medical Oncology (ESMO) meeting, the latest data from the NATALEE trial were presented, showing a deeper benefit in invasive disease-free survival (iDFS) across subgroups of patients at the end of the three-year treatment period. In addition, for patients with stage II and III HR+/HER2- early stage breast cancer, they often face a significant risk of recurrence and may even develop incurable metastatic disease, despite receiving adjuvant endocrine therapy (ET) and regardless of lymph node involvement. Kisqali has already been approved for HR+/HER2- metastatic breast cancer as early as 2020 and is currently under regulatory review for an early breast cancer indication worldwide, including in the European Union.

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 19, 2024 /PRNewswire/ -- USA News Group – In the oncology world, there's been plenty to celebrate recently, with cancer deaths falling by 33% in the last 30 years. However, there's still a lot of work to do in the war on cancer, with the 2024 World Cancer Congress in Geneva highlighting several issues, such as artificial intelligence (AI), conflict zones and crisis care taking center stage at the gathering. Plenty of support for research continues to roll in, with philanthropists recently giving a historic $150 million for pancreatic cancer research to City of Hope, while Stanford experts are calling for more massive federal funding increases to cancer research. At the research level, several players are making significant progress in oncology, with recent developments coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), Lantheus Holdings, Inc. (NASDAQ: LNTH), Sutro Biopharma, Inc. (NASDAQ: STRO), and Zymeworks Inc. (NASDAQ: ZYME). Backed by favorable results in its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has recently reported important strides towards a registration-enabling study for its flagship asset pelareorep. The recently completed BRACELET-1 randomized phase 2 study ended with favorable optimism in its evaluation of pelareorep's ability to benefit patients with HR+/HER2- advanced or metastatic breast cancer. Within the latest update on pelareorep's latest breast cancer study were plenty of reasons to build optimism, corroborating results of its previous randomized IND-213 breast cancer study that led to an FDA Fast Track Designation in 2017. One important piece of data revealed was the promising fact that the median overall survival (OS) for pelareorep combined with paclitaxel was not reached, meaning more than half the patients in that arm remained alive at the end of the study. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." According to Oncolytics, had the study continued beyond two years, and patients survived only until the next planned visit (in 4 months), the median OS for patients in the pelareorep + paclitaxel arm would be 32.1 months, with a recorded hazard ratio of 0.48 vs the monotherapy. In accordance with these results, the two-year survival rate for patients in this arm was 64% compared to 33% for paclitaxel monotherapy patients. Additionally, the final median progression-free survival (PFS) for BRACELET-1 was 12.1 months in the pelareorep + paclitaxel arm vs 6.4 months in the paclitaxel monotherapy arm, representing an extra 5.7-month benefit with a hazard ratio of 0.39. The confirmed overall response rate (ORR) for the pelareorep + paclitaxel combo was 37.5%, whereas paclitaxel alone was 13.3%. Also, as previously reported, ORRs at week 16 (the trial's primary endpoint) in the combo was 31%, whereas the monotherapy was 20%. Now, Oncolytics is setting its sights on the next stage of pelareorep's journey towards a potential FDA approval, with a newly reinforced path to funding a registration-enabling study. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." For patients with metastatic HR+/HER2- early-stage breast cancer, the FDA recently expanded its approval of drugmaker Novartis AG's (NYSE: NVS) Kisqali, which is currently under regulatory review worldwide, including in the EU for the early breast cancer indication. This latest approval is based on results from the pivotal Phase III NATALEE trial, which showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence. "The FDA approval of Kisqali for this early breast cancer population, including those with N0 disease, is a pivotal moment in improving our approach to care," said Dennis J. Slamon, M.D., Director of Clinical/Translational Research, UCLA Jonsson Comprehensive Cancer Center and Chairman of the Board of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator. "Today's approval allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning." In Barcelona, Spain, leading radiopharmaceutical-focused company Lantheus Holdings, Inc. (NASDAQ: LNTH) recently presented data from the primary analysis of its Phase 3 pivotal SPLASH trial in PSMA-positive metastatic castration-resistant prostate cancer during the European Society of Medical Oncology (ESMO) Congress 2024. As per the results, Lantheus announced that its study met its primary endpoint, evaluating the efficacy of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), demonstrating significant improvement in radiographic PFS, with an ORR of 38.1% vs 12% for the ARPI switch arm, and also reported 9.3% complete responses (CR). Overall survival data continued to mature, with an update expected once data are available for 75% of protocol-specified target OS events. "We are encouraged by the initial results from the SPLASH trial, with 177Lu-PNT2002 demonstrating improvement compared to ARPI change in radiographic progression-free survival, positive interim crossover-adjusted overall survival hazard ratios, as well as improved quality of life," said Oliver Sartor, M.D., Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota. "These initial data underscore the importance of PSMA-targeted RLTs, including 177Lu-PNT2002, as potential treatment options for patients who have limited choices after progressing on ARPI therapy." Sutro Biopharma, Inc. (NASDAQ: STRO) also presented at ESMO 2024, sharing updated data through a poster presentation from its Phase 1b study of its antibody-drug conjugate Luvelta, in combination with bevacizumab for patients with epithelial ovarian cancer (EOC). In the study, the combination demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer irrespective of Folate Receptor-α (FRα) expression, including patients with no FRα expression, and prior bevacizumab treatment, with an overall response rate of 35%. "We are encouraged by these results achieved with luvelta in combination with bevacizumab, which may offer the opportunity to benefit ovarian cancer patients regardless of FRα expression," said Jane Chung, President and Chief Operating Officer of Sutro. "We have already seen promising antitumor activity with luvelta as a monotherapy treatment and we believe these combination data support our goal to deliver effective therapies to more patients living with cancer. We look forward to sharing initial results from our expansion phase in the first half of 2025." Also in Barcelona, but in October, Zymeworks Inc. (NASDAQ: ZYME) is preparing to present preclinical data on its antibody-drug conjugate programs at the European Organisation for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) Conference being held October 23-25, 2024. The clinical-stage biotech company is developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat cancers and other diseases, and plans to host two presentations highlighting results from recent preclinical research for Zymeworks' antibody-drug conjugate candidates ZW220 and ZW251. "We are excited to share results from our preclinical studies, which highlight the activity of ZW220 in models of non-small cell lung, ovarian, and uterine cancers, as well as ZW251 in hepatocellular carcinoma models, both of which leverage our novel proprietary payload, ZD06519," said Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "We are encouraged by the progress of these next-generation ADC programs, which remain on track for IND filings in 2025, following the recent advancement of ZW171 and ZW191, which are currently recruiting for Phase 1 studies." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

WEDNESDAY, Sept. 18, 2024 -- Women with early stage breast cancer may now take Kisquali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration's expanded approval of the treatment, drug maker Novartis announced Tuesday. “The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn't spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr. Dennis Slamon , director of clinical/translational research at UCLA's Jonsson Comprehensive Cancer Center and lead investigator on the company's trial of the drug. “Today’s approval allows us to offer treatment with a CDK4/6 inhibitor [Kisquali] to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning,” he added in a company news release . What prompted the expanded approval? In a phase 3 clinical trial involving women with earlier stage cancers, Kisqali reduced the risk of a breast cancer coming back by 25% after three years when given along with standard treatments, which can include chemotherapy, surgery and radiation followed by hormone therapy. After four years, Kisqali reduced the risk by 28.5%, according to an updated analysis presented Monday at the European Society for Medical Oncology annual meeting in Barcelona. “We want to do everything that we can to incrementally decrease the chances of this cancer coming back,” Dr. Vandana Abramson , co-leader of the Breast Cancer Research Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tenn., told NBC News. “So if a patient was already at a potentially 10% risk of the cancer coming back, this would decrease it further, down to 7%.” While Verzenio , a drug in the same class, has been approved to lower the risk of early breast cancer returning, it's only for people with a very high risk of recurrence. Kisqali will be available to a much broader group of patients, whose disease may not be as aggressive at the time of diagnosis, Novartis said. The expanded approval is for patients with HR-positive, HER2-negative breast cancer, the most common form of the disease. It's for stage 2 and 3 cases, meaning the cancer hasn’t spread beyond the breast or nearby lymph nodes. While the drug’s effects were studied for three years, research has shown that breast cancer can recur decades after diagnosis. “It would be nice to still see additional longer follow-up data to see if we are impacting just rates of early recurrences, or will we also have an impact on late recurrences?” Dr. Komal Jhaveri , a breast medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told NBC News . Still, the drug will not come cheap. “The cost, out-of-pocket, if you’re taking it for the entire three years, would be close to $300,000-$400,000,” Abramson noted. With the expanded approval, it’s more likely that insurance plans will offer coverage for the treatment, but that can still tax the health care system as a whole. “Some of the criticisms of the study have been: well, it was only a 3% benefit,” Dr. Eleonora Teplinsky , head of breast and gynecologic medical oncology at Valley Health System in New Jersey, told NBC News. “Three percent more patients benefit. What does that mean? But I think that’s then up to the patient to decide what they want to do. It’s important for them to have the option.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.