CureVac’s Post

5 Clinical trials to expect in the first half of 2024 🔍 New #ClinicalTrials bring us closer to treatments for the most complicated diseases. The first half of 2024 looks promising, with several trials poised to offer new hope and potential to transform patient care. Here's a sneak peek at some of the trials that have caught my eye: 1️⃣ Vertex Pharmaceuticals They develop VX-548, a potential non-addictive painkiller that can revolutionize acute pain treatment. 2️⃣ Alnylam Pharmaceuticals  The HELIOS-B trial can redefine treatment standards for transthyretin amyloidosis cardiomyopathy, offering hope for a more effective treatment. 3️⃣ Roche Skyscraper-01 trial results may shed light on TIGIT-targeted cancer immunotherapy's efficacy in advanced lung cancer. 4️⃣ Amylyx Pharmaceuticals The Phoenix trial aims to validate Relyvrio's potential as a groundbreaking ALS treatment. 5️⃣ Johnson & Johnson Aticaprant's Phase 3 trial seeks to offer new hope for major disorders, aiming to improve patient outcomes and quality of life. What upcoming trials excite you the most? Wellcome to the comments. 

🔬 Exciting FDA Approval: Elevating Colon Cancer Screening Standards 🔬 At Lampgen Clinical Research, we are thrilled to share the news of the FDA’s approval of Exact Sciences’ Cologuard Plus, a revolutionary advancement in colon cancer screening. This stool-based test is setting new benchmarks in the accuracy and ease of early cancer detection, significantly reducing false positives and the need for unnecessary follow-up procedures. As specialists in oncology CRA staffing, we understand the profound impact of such innovations on clinical trials and patient outcomes. Cologuard Plus, with its enhanced detection capabilities, represents a major step forward in non-invasive cancer screening, promising to extend its benefits to a broader population. This breakthrough exemplifies why we are passionate about staffing the best CRAs in the industry—to ensure such important trials are conducted with the utmost precision and care. #CancerResearch #FDAApproval #ColonCancerAwareness #ClinicalTrials #Oncology #HealthcareInnovation #LampgenClinicalResearch #CRAStaffing #MedicalAdvancements #ScreeningSavesLives https://lnkd.in/ezgXDcTZ

The FDA has granted approval for the combination of amivantamab (Rybrevant) and lazertinib (Lazcluze) as a first-line treatment for adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC). This milestone offers a new therapeutic option for patients with EGFR exon 19 deletions or exon 21 L858R substitution mutations, addressing a significant unmet need in the oncology community. The decision is underpinned by robust data from the Phase 3 MARIPOSA trial, where the amivantamab/lazertinib combination demonstrated a 30% reduction in the risk of progression or death compared to osimertinib (Tagrisso). The combination therapy also yielded a median progression-free survival (PFS) of 23.7 months versus 16.6 months for osimertinib, marking a substantial advancement in the treatment landscape for EGFR+ NSCLC. Key findings: Objective Response Rate (ORR): 86% with amivantamab/lazertinib vs 85% with osimertinib. Median Duration of Response (DOR): 25.8 months for the combination therapy vs 16.8 months for osimertinib. Overall Survival (OS): Encouraging trends with a hazard ratio of 0.80. As Jill Feldman, a lung cancer survivor and co-founder of the EGFR Resisters advocacy group, aptly noted, "This approval is a crucial development for patients with EGFR-mutated NSCLC, who have faced significant unmet needs for far too long." For healthcare professionals and patients alike, this approval signifies a critical step forward in personalized cancer therapy, offering renewed hope and extended survival. #Oncology #LungCancer #NSCLC #EGFR #FDAApproval #Amivantamab #Lazertinib #TargetedTherapy #CancerResearch #MedicalWriting 🔗 Read the full details: https://lnkd.in/dDWD8d3j

Johnson & Johnson's #RYBREVANT® (amivantamab-vmjw) plus #LAZCLUZE™ (lazertinib) approved by #FDA as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. This approval is based on positive results from the Phase 3 #MARIPOSA study. Let's analyze it .. The clinical trial NCT04487080, known as the MARIPOSA study focuses on evaluating ''amivantamab'' combined with ''lazertinib'' as a first-line treatment for patients with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (#NSCLC). • Study Design: Phase 3, randomized study comparing three treatment regimens: ''amivantamab + lazertinib'', ''osimertinib'' alone, and ''lazertinib'' alone. • Participants: Patients with EGFR-mutant NSCLC, either locally advanced or metastatic. • The trial suggests that the combination therapy could be an effective chemo-free regimen offering a new standard of care for this patient population. • Outcomes : ✅ Risk Reduction: The combination of Rybrevant® (amivantamab) and Lazcluze™ (lazertinib) reduced the risk of disease progression or death by 30% compared to osimertinib. ✅The median Progression-Free Survival for patients treated with Rybrevant® + Lazcluze™ was 23.7 months compared to 16.6 months for osimertinib. ✅The median Duration of Response for the combination therapy was 25.8 months which was nine months longer than the DOR for osimertinib (16.7 months). Updated follow-up data from the MARIPOSA study will be presented at the 2024 World Congress on Lung Cancer (#WCLC) hosted by the International Association for the Study of Lung Cancer (#IASLC) in September. #RYBREVANT #LAZCLUZE #FDAApproval #EGFRMutations #LungCancerTreatment #NSCLC #JohnsonAndJohnson #MARIPOSAStudy

That's a wrap on Day 1 of #ASCO2024. The conference is brimming with innovation and optimism as some of medicines' brightest minds share work and discoveries that are prolonging the lives and bettering outcomes for cancer patients.   Key takeaways for today:   ✅ Lorlatinib. A staggering 60% of patients, all with advanced forms of metastatic, non-small lung cancer, alive after five years on the drug (compared to 8% on the standard drug) AND recording no disease progression. The results are being noted as "off the chart" and "unheard of". Pfizer's Lorlatinib is being noted as stopping lung cancer from advancing longer than any other treatment in medical history.   ✅ High-Deductible Plans. Alarming findings were presented from Dr. Justin Barnes from Washington University in St. Louis which showed that patients with high-deductible ($1,200-$1,350 individual and $2,400 - $2,700 family) had a greater risk of mortality both overall and from cancer in comparison to their peer set with a low-deductible plan.   ✅ Brenetafusp. Immunocore shares promising updated Phase I data for Brenetafusp, an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients. #oncology #cancercare #ASCO2024 #viscadia

A new promise for MMR-deficient/MSI-H advanced rectal cancers? One of the recent ASCO highlights was the late-breaking data by GSK on the continuous success of the Jemperli (dostarlimab) Phase II ongoing trial in partnership with Memorial Sloan Kettering Cancer Center. 💥All 42 patients with locally advanced rectal cancer who completed dostarlimab treatment showed a 100% clinical complete response rate. 💥The data showing no evidence of disease in these patients is remarkable indeed, with the additional benefit of a safety profile superior to the standard of care treatment. As Dr. Andrea Cercek, the PI of the study commented "I’ve seen firsthand the debilitating impact of standard treatment of dMMR rectal cancer and am thrilled about the potential of dostarlimab in these patients." 👉 This drug is currently approved in MMR-deficient recurrent or advanced endometrial cancers in US and Europe, and now is being evaluated as monotherapy for treatment-naive rectal cancer patients through GSK's AZUR clinical trial programme (Jemperli (dostarlimab) trial continues to show unprecedented results with no evidence of disease in 100% of patients with locally advanced mismatch repair deficient (dMMR) rectal cancer | GSK). Precision medicine in action. #precisionmedicine, #GSK, #biomarkers; #oncology

#LungCancer Advancement: Noticeable Improvement in Survival Rates A significant development in lung cancer treatment has emerged with the introduction of lorlatinib, a drug making headway as a leading treatment option for this widespread illness. Recent trials have demonstrated a noteworthy delay in disease progression. Given that lung cancer is the leading cause of cancer death worldwide, taking 1.8 million lives each year, the challenge has been in managing its more advanced stages. Lorlatinib represents a substantial improvement, with 60% of patients with advanced non-small cell lung cancer experiencing stable disease for up to five years, far exceeding the 8% survival rate with previous therapies. Unveiled at the @American Society of Clinical Oncology in Chicago, these findings are more than just statistics— Lorlatinib offers the possibility of extended survival and enhanced quality of life, marking a significant step forward in the field of medicine. The impact of lorlatinib is especially noteworthy for patients with ALK positive variants, opening up prospects of long-term disease management. As we consider these pivotal results, it's clear that each scientific breakthrough brings us closer to transforming cancer from a terminal diagnosis to a manageable condition. We continue to advance, propelled by each discovery. #CancerResearch #MedicalInnovation #ProgressInCancerCare

Today is #RareDiseaseDay – a day to raise awareness for the 300 million people worldwide living with a rare disease, their families and carers.    Observed annually on the rarest day of the year – the 28th/ 29th of February – the day is largely patient-led, but everyone from the general public to healthcare professionals and industry representatives has a part to play.    Surprisingly, 1 in 5 cancers is classified as a rare disease, including Acute Myeloid Leukaemia (AML). Unfortunately, the 5-year survival rate is lower for patients with a rare cancer than for those diagnosed with a more common cancer.    Here at BiVictriX, we are working hard to provide better targeted therapeutics to meet the significant unmet need in the AML space. Our lead therapeutic, BVX001, is a bispecific ADC showing substantially improved cancer cell selectivity and therapeutic activity, and we are excited to be making continued progress towards a first-in-human study.     Still need some more information about Rare Disease Day? Check out their insightful video here: https://lnkd.in/dXijzgdd or head to their website: https://lnkd.in/gk6hbAF    And you can read more about BVX001 here: https://lnkd.in/eBHU7BJH    #RareDiseaseDay2024 #AcuteMyeloidLeukemia #AML #Cancer #Biotherapeutics #Therapuetics #CancerTreatment #RareDisease #Oncology #Antibody #ADC Rare Disease Day

Honoured to be co-author (a very minor role) on this new research as a Lobular Breast Cancer UK and European Lobular Breast Cancer Consortium (ELBCC/COST Lobsterpot) patient advocate. Collaboration is so key for better understanding and treatments for everyone with a Lobular Breast Cancer diagnosis. This systematic review (a critical appraisal of previous research studies with a description and analysis of their findings)led by Karen Van Baelen involved health professionals, researchers and patient advocates from around the world. “It is important to acknowledge the poor documentation and under- representation of ILC (Invasive Lobular Carcinoma) in clinical trials since it impedes the personalized treatment of all patients diagnosed with ILC….It is clear that urgent efforts are needed to accommodate patients with ILC.” The research concludes that “Eligibility criteria and definitions of treatment response need to be re- evaluated to better reflect the unique biology of ILC. It is critical that patients with ILC are considered by clinical investigators and pharmaceutical industries” when designing, running and reporting on trials.” https://lnkd.in/evmJicU7 #ILC #LobularBreastCancer #Lobular Lobular Breast Cancer Alliance Inc. LobularIreland Ireland #GlobMob

This post is intended for a US audience. When we make a promise to the patient community, we deliver. And we count today as a promise kept: the FDA approved AstraZeneca’s medicine for limited-stage small cell lung cancer (LS-SCLC). Our treatment now stands alone as the first and only immunotherapy regimen demonstrating a survival benefit approved for this patient population. This breakthrough has been a long time coming. The standard of care has been in place for nearly four decades and not been effective in blunting the recurrence and rapid progression of LS-SCLC. Until now. We knew the potential to revolutionize the patient experience a few months ago, when the crowd at ASCO leapt to their feet when the ADRIATIC trial results were unveiled. The data showed significant survival benefits with our medicine for patients who had not progressed following concurrent chemoradiotherapy (cCRT). Patients saw a 27% reduced risk of death and a 24% reduced risk of progression or death. Nearly 50% of patients had no disease progression at the two-year mark and 57% of patients were still alive at the end of three years. Rewriting the future of lung cancer care means helping more patients have a future to look forward to. We’re charging even harder to transform outcomes and extend survival for every patient at every stage, with more beneficial therapies on the horizon. Read more about today’s news: http://bit.ly/49s1kUD #USOnly #AstraZenecaUS