Amplity Health’s Post

At #AmplityHealth, our contract sales, medical, and communications experts have a front-row seat in advancing #immunotherapy and #precisionmedicine to combat cancer more effectively with our biopharma clients. Here are some key highlights from #ASCO24 Day 1: - Discussion of newly FDA-approved oncology agents - Presentation of 5 years of data from the CROWN study comparing lorlatinib and crizotinib in new patients with advanced ALK-positive non-small cell lung cancer - Analysis of research into whether circulating tumor DNA can help predict the effectiveness of neoadjuvant chemotherapy and evaluate the prognosis for those with early breast cancer View our full Day 1 summary and join our mailing list for updates: https://lnkd.in/euzvmUPG

This post is intended for a US audience:   Today we announced the US FDA granted Priority Review for our HER2-directed antibody drug conjugate (ADC) – which we develop in collaboration with Daiichi Sankyo – for the potential treatment of certain patients with metastatic HER2-positive solid tumors.   HER2-directed therapies have been used for decades in breast cancer, where they have transformed outcomes for patients. Only recently has HER2 emerged as a treatment target for other types of solid tumors, creating an opportunity for us to address an important unmet need in patients. If approved, our ADC would potentially be the first HER2-directed treatment to receive a tumor-agnostic indication, aiding in our mission to redefine cancer care. Learn more about the news: https://lnkd.in/e_8Rajn3 #USOnly #AstraZenecaUS

📣‼️ The Union for International Cancer Control (UICC) was founded in 1933 as a call to action on cancer. 👉🏼 World Cancer Day 2024 is the third and final of their "Close the care gap" campaign, created as a call to action for governments to reduce inequities related to patient access to quality cancer care and services. 👉🏼 Please join US FDA Oncology Center of Excellence, the European Medicines Agency, and #patients for a panel discussion on regulatory programs that quicken therapeutic access to patients. #cancer #cancertreatment #patientcare #patientcentricity 👇🏼

Merck Expands Oncology Pipeline with Harpoon Therapeutics Acquisition 🌐 Merck has announced its acquisition of Harpoon Therapeutics ,a strategic move to diversify its oncology pipeline. Harpoon Therapeutics is renowned for its cutting-edge Tri-specific T cell Activating Construct (TriTAC) platform, a technology that uniquely harnesses the body's immune system to target and destroy cancer cells Harpoon's lead, HPN328, targets delta-like ligand 3 (DLL3), significant in small cell lung cancer (SCLC) and neuroendocrine tumors. It's under a Phase 1/2 trial, exploring its efficacy both as a monotherapy and combined with atezolizumab in SCLC patients. October 2023 brought promising interim data for HPN328, especially in SCLC and neuroendocrine tumors. Moreover, Harpoon's pipeline includes HPN217 for relapsed/refractory multiple myeloma, currently in Phase 1 trials, and HPN601, a preclinical candidate targeting EpCAM in certain tumors. This acquisition indicates Merck's dedication to pushing the boundaries of cancer therapy. #cancertherapy #pharmanews

Day 2 of the Inaugural AACR Oncology Industry Partnering Event was just as informative as Day 1! During a session with the FDA, key messages were shared about the future of cancer treatment. Here are some of the highlights: 🔹 increase in multi-modality approaches to targets, including small molecule, ADC, and radioligand therapy. 🔹 A multi-target approach is necessary to address cancer. 🔹 Immunologically cold tumors, such as prostate and pancreas, are particularly challenging to combat. 🔹 Confirmatory trials are required to start in a timely manner for accelerated approvals. 🔹 Dose optimization prior to phase III is crucial. 🔹 Response rate remains a critical endpoint for drug approval decisions. 🔹 Are clinical trial designs becoming too complicated? #pragmatica

Where, how and why can complex issues like circulating tumor DNA, and by extension, minimal residual disease help us to drive novel trial designs that are more patient friendly and concurrently can expedite the safety and efficacy evaluations of novel therapeutics? In this episode of the Syneos Health Podcast, Chief Scientific Officer Nick Kenny is joined by oncology experts Warl Harb and Patrick Kelly to discuss how circulating tumor DNA (ctDNA) is transforming cancer treatment and clinical trial design, and its potential to drive more patient-centric, adaptive clinical trials. Listen to the full episode: https://ow.ly/cgS730sHl2M

Join the FDA Oncology Center of Excellence for a Conversation on Cancer on Feb. 1 in recognition of World Cancer Day. The conversation will focus on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma. The discussion will provide an overview of regulatory programs that expedite access to patients, including FDA’s Breakthrough Therapy designation and Accelerated Approval; and the European Medicines Agency’s Prime and Conditional Approval. The panel of patients, investigators and regulators aims to highlight successes from development to approval. This is the second collaboration between OCE and the EMA in this public panel discussion series. Register here: https://lnkd.in/eNM-Gjns #OCEProjectCommunity #cancer #drugdevelopment #FDA #EMA

𝗠𝗲𝗿𝗰𝗸, 𝗞𝗲𝗹𝘂𝗻 𝘁𝗿𝘂𝗺𝗽𝗲𝘁 𝗣𝗵𝗮𝘀𝗲 𝟯 𝗯𝗿𝗲𝗮𝘀𝘁 𝗰𝗮𝗻𝗰𝗲𝗿 𝗱𝗮𝘁𝗮 𝗳𝗼𝗿 𝗮𝗻𝘁𝗶-𝗧𝗥𝗢𝗣𝟮 𝗔𝗗𝗖 Merck and Kelun LifeSciences (Pvt)Ltd-Biotech revealed Phase 3 breast cancer data for the lead antibody-drug conjugate in their potentially $12 billion partnership. In a Phase 3 trial for locally recurrent or metastatic triple-negative breast cancer, the anti-TROP2 ADC sacituzumab tirumotecan (previously known as SKB264/MK-2870) reduced patients’ risk of disease progression or death (PFS) by 69% compared with chemotherapy. Additionally, patients’ overall risk of death (OS) was reduced by 47%. Both results were statistically significant. https://lnkd.in/drDavMAf

Keytruda Redeems Itself in Head and Neck Cancer as Merck Lands Potential $1.9B I&I Collaboration On the heels of Keytruda’s success in a Phase III perioperative trial for a disease where it had previously failed to improve event-free survival, Merck touts an I&I deal with UK biotech Mestag. After a 2022 failure, Merck’s mega-blockbuster has rallied in head and neck cancer. The company dropped data from a successful Phase III trial as a perioperative treatment for patients with late stage, resected, locally advanced head and neck cancer. https://lnkd.in/gRPERdku #HealthCare #Pharmacy #ClinicalTrials #Cancer #Carcinoma #Keytruda #Merck #Mestag

New in The Innovation Life! Innovative drugs bring continuous benefits to cancer patients. Huang and Cao summarized essential information about target points, cancer types, and the progress of clinical trials for pivotal innovative anti-cancer drugs. Read more @InnovationLife https://lnkd.in/e-NUSucq #Cancer #anticancer #drugs #clinical #medicine #research #innovation