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IRVINE, Calif. & AMSTERDAM--( BUSINESS WIRE )-- Agendia ® , Inc. , announced today it will share new data from the ongoing prospective, observational FLEX Trial ( NCT03053193 ) in two poster presentations at the 41 st Annual Miami Breast Cancer Conference (MBCC), taking place March 7 – 10 th , 2024. The first poster, titled MammaPrint ® and BluePrint ® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.), investigates the associations between MammaPrint and BluePrint classifications, therapy regimen, and the likelihood of achieving a pathologic Complete Response (pCR). Researchers looked at patients who had hormone receptor-positive (HR+), Human Epidermal Growth Factor Receptor (HER) 2-negative early-stage breast cancer – categorized as MammaPrint High Risk – who had been treated with either a combination of two (taxane and cyclophosphamide, TC) or three (TC with anthracycline, AC-T) types of neoadjuvant chemotherapy. Patients were then further stratified into MP High 1 and High 2 categories, and further stratified by BluePrint subtype of Luminal and Basal. Results showed that patients with MP High 2 tumors, including Luminal B and Basal subtypes, are more likely to achieve a pCR in response to AC-T, while the addition of anthracycline to the therapy regimen does not appear to improve pCR rates for patients with MP High 1, Luminal B-type tumors. The second poster, titled Prediction of chemotherapy benefit by MammaPrint ® in patients with HR+HER2-early-stage breast cancer from real-world evidence studies (Audeh, W., et al.), used data from patients with HR+ HER2-negative early-stage breast cancer enrolled in the FLEX and NBRST trials to generate a prediction of the magnitude of chemotherapy benefit based upon a patient’s genomic risk, looking at the MammaPrint index more closely as a continuous variable. Researchers examined the association of the MammaPrint index with benefit from chemotherapy by evaluating two clinical endpoints, the likelihood of pCR in response to neoadjuvant chemotherapy, and the five-year outcome among patients who received chemotherapy and endocrine therapy or endocrine therapy alone. Consistent with results found in the landmark MINDACT trial, this study showed that the MammaPrint index demonstrates strong efficacy in predicting low chemosensitivity in Low Risk and Ultra Low Risk tumors, reinforcing that these groups do not derive significant chemotherapy benefit. However, it was also observed that chemotherapy effectiveness increased as MammaPrint risk increased in High 1 and High 2 tumors, as evidenced by both pCR rates and 5-year outcomes, demonstrating that the overall benefit of chemotherapy increases as MammaPrint risk increases. Taken together, these findings indicate the utility of MammaPrint to predict neoadjuvant and adjuvant chemotherapy benefit in this patient population. “In this unique real world evidence FLEX study, we were able to look at chemosensitivity for patients who had received neoadjuvant treatment and the chemo benefit for patients who are treated with systemic therapy after surgery, showing that MammaPrint is predictive of chemotherapy benefit in both cases. The FLEX Trial, with over 16,000 women enrolled, is now allowing us to look at clinical outcomes as well as analyzing whole transcriptome data,” said William Audeh, MD, MS, Chief Medical Officer of Agendia. “The data we’re sharing at the Miami Breast Cancer Conference confirms that gene expression profiling with these assays identify who may benefit from chemotherapy, and may prove helpful in regimen selection as well. We look forward to further exploring the capabilities of MammaPrint and BluePrint for women across the entire spectrum of breast cancer risk and subtype.” The goal of Agendia’s research is to increase the likelihood of managing each individual’s cancer diagnosis by delivering a customized treatment plan to the patients most likely to benefit based on the unique features of their tumor. About Agendia Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint ® + BluePrint ® , enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment. Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer. About MammaPrint MammaPrint ® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman's risk of distant metastasis, MammaPrint ® provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint® listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories - ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life's plans. About BluePrint BluePrint ® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint® measures the activity of 80 key genes that are involved in a tumor's growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman's tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.

Pictured: J&J building in Madrid, Spain/iStock, BrasilNut1 The FDA on Friday approved Johnson & Johnson’s bispecific antibody Rybrevant (amivantamab-vmjw) for the first-line treatment of locally advanced non-small cell lung cancer in combination with carboplatin and pemetrexed. Friday’s regulatory victory, which also converts Rybrevant’s accelerated approval into a traditional approval, allows the use of the Rybrevant-based combination regimen in patients with confirmed exon 20 insertion mutations in the EGFR gene, as determined by an FDA-approved test. The approval also makes Rybrevant, when used with a chemotherapy regimen, the “first targeted approach approved for the first-line treatment” of this specific patient population, Kiran Patel, vice president of clinical development, solid tumors at J&J Innovative Medicines, said in a statement. The FDA’s decision was backed by data from the randomized, open-label Phase III PAPILLON trial, which demonstrated that the Rybrevant-based regimen cut the risk of disease progression or death by 60% versus chemotherapy alone. The objective response rate was also significantly improved following treatment with the Rybrevant combo, according to an October 2023 readout. At the time, overall survival also showed a positive trend in favor of the Rybrevant combo, though this result did not reach statistical significance. Administered via an intravenous infusion, Rybrevant is a bispecific antibody that targets both the EGF sand MET receptors. This mechanism of action allows Rybrevant to block the EGF and MET signaling cascades, preventing the cancer cells’ uncontrolled division and proliferation while also tagging these receptors for degradation, according to the website of J&J subsidiary Janssen. Rybrevant also marks the tumor cells for destruction by immune cells, such as macrophages and natural killer cells. The FDA granted Rybrevant accelerated approval in May 2021 for the treatment of metastatic or locally advanced non-small cell lung cancer patients with EGFR exon 20 insertion mutations and who had progressed on or after platinum-based chemotherapy. PAPILLON was J&J’s confirmatory trial for Rybrevant. The company is also evaluating Rybrevant in combination with lazertinib, an oral EGFR tyrosine kinase inhibitor that targets the T790M mutation, among other activating EGFR mutations. In September 2023, J&J released topline data from the Phase III MARIPOSA study demonstrating that the treatment combo met its primary endpoint, significantly boosting progression-free survival versus AstraZeneca’s Tagrisso (osimertinib). The same month, J&J posted data from another Phase III trial—dubbed MARIPOSA-2—showing that Rybrevant, with or without lazertinib, significantly improved progression-free survival in patients who had progressed after Tagrisso treatment. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

A still from Pfizer’s “Here’s to science” advertisement, which aired during the Super Bowl. Thirty-second ad slots are reported to cost $7m. The Super Bowl is the most expensive and high-stakes game for TV commercial advertising, and the pharma industry spared no expense to collect on some of the night’s most coveted airtime. Pfizer ran its first-ever Super Bowl ad “Here’s to science,” which included a lineup of scientists who stood at the frontier of knowledge. Alongside the company’s founders Charles Pfizer and Charles F Erhart, the 60-second ad featured computer-generated images of pioneers such as Sir Isaac Newton, Albert Einstein, Rosalind Franklin, and Marie Maynard Daly singing along to Queen’s “Don’t Stop Me Now.” Super Bowl viewers were treated to the discovery of penicillin and the work done by Katalin Karikó and Drew Weismann in mRNA, which won them the 2023 Nobel Prize in Medicine and was used in developing Covid-19 vaccines such as Pfizer’s Comirnaty. The company then took the opportunity to highlight its “next fight” against cancer, where Pfizer has made significant strides. In December 2023, Pfizer completed its acquisition of Seagen , a leader in developing antibody-based therapies for cancer. Pfizer plans to create an oncology division dedicated to the oncology-related R&D and commercial activity of both Pfizer and Seagen. Multiple news sources have reported that a 30-second ad for this year’s big game cost $7m on average. In between amnesia-ridden Uber Eats shoppers and Ben Affleck’s Boston DunKings, Astellas provided women with the solution to menopause-related hot flashes with its “Fewer Hot Flashes, More Not Flashes” commercial. See Also: GS-0201 by Gilead Sciences for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval GS-0201 by Gilead Sciences for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval Astellas made a bid to gain traction during the highly viewed event for Veozah (fezolinetant), a non-hormonal treatment launched last year. It is designed to block neurokinin 3 (NK3) receptor binding and modulate neural activity in the thermoregulatory centre of the brain. It is approved to treat moderate to severe vasomotor symptoms caused by menopause. Through the ad, the company wanted to empower women to be more open about their experiences and consult with their healthcare providers to seek appropriate treatments for these symptoms, said Jill Jaroch, senior director of Women’s Health at Astellas in a 1 February press release. With around half the audience being women, the Super Bowl is an “incredible platform” to normalise the conversation around vasomotor symptoms and menopause, she added. Given its status as the first neurokinin antagonist option for vasomotor symptoms, Veozah is expected to be a big-ticket drug. As per GlobalData, the drug is forecasted to bring in $1.9bn in sales in 2029. GlobalData is the parent company of Pharmaceutical Technology .