4+ mon, 3+ week ago (320+ words) David Spigel, MD, discusses the pivotal findings from the AIM-HIGH trial in early-stage non-squamous NSCLC. David Spigel, MD, medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, discusses the pivotal findings from the AIM-HIGH trial (NCT01817192), a study poised to reshape how clinicians approach adjuvant chemotherapy in early-stage non-squamous non'small cell lung cancer (NSCLC). The trial was designed to evaluate disease-free survival, but was halted early by the Data Safety Monitoring Board due to overwhelming evidence of benefit in the chemotherapy group. "The 2-year disease-free survival hazard ratio was 0.22or in other words, there was a 78% reduction in the risk of cancer returning or dying in those patients with intermediate or high-risk disease who received chemotherapy compared with just being observed," Spigel explains. These findings support the growing role of precision oncology in early-stage NSCLC and…...

4+ mon, 1+ week ago (515+ words) During a live event, Christine Bestvina, MD, reviewed outcomes from the phase 3 KRYSTAL-12 and CodeBreak 200 trials in the KRAS-mutated non'small cell lung cancer population. Targeted Oncology: What data confirmed the efficacy and safety of adagrasib for patients with KRAS-mutated NSCLC? What were the safety outcomes with adagrasib in this trial? As far as safety, approximately 47% in both arms had some grade 3 toxicity. However, it was decently well tolerated in both arms. Very rarely did adagrasib need to be discontinued, in only 8% of patients [vs 14% with docetaxel]. I think that number is really important. What randomized trial data supported the use of sotorasib in this population? PFS was the primary end point here, [with a median of] 5.6 months with sotorasib vs 4.5 months with docetaxel, and the HR was 0.66 [95% CI, 0.51-0.86; P = .0017], which did meet statistical significance, so this was a positive trial....

9+ mon, 2+ week ago (262+ words) The FDA makes furthering moves in SCLC, ovarian, and breast cancers, and the value of remote clinical pharmacists is explored in community oncology. 225Ac-SSO110, an SST2 antagonist, Granted Orphan Drug Status in SCLC "..The FDA's ODD will support our objective to accelerate the development of 225Ac-satoreotide through human trials to provide a potentially life-saving therapy to patients with limited alternatives," said Manfred R'diger, chief executive officer at Ariceum Therapeutics, in a press release. For more information regarding 225Ac-satoreotide, access the full article here. Unveiling Key Insights Behind the Dato-DXd Approval for HR+/HER2" Breast Cancer FDA Bestows RMAT Designation on Gemogenovatucel-T in Ovarian Cancer "This important recognition affirms that [gemogenovatucel-T] has the potential to extend patient survival and may offer a safer, more precise therapeutic approach to a population in urgent need of innovative solutions," said David Shanahan, chief executive officer of Gradalis,…...

2+ mon, 4+ week ago (63+ words) This week in oncology highlights breakthroughs in cancer diagnostics and therapies, offering new hope for patients with colorectal, brain, ovarian, and breast cancers. The Targeted Pulse: Pivotal Advancements in Clinical Oncology The Targeted Pulse: A Weekly Wrap-Up of Key Clinical Oncology News The Targeted Pulse: Your Weekly Oncology Wrap-Up The Targeted Pulse: FDA Designations, Access Gaps, and Strategic Advances in Oncology...

6+ mon, 2+ week ago (493+ words) Ariel Lopez-Chavez, MD, medical oncologist, director of precision medicine and developmental therapeutics at Allegheny Health Network Cancer Institute, discusses comprehensive genomic profiling and ... Ariel Lopez-Chavez, MD, discusses the role of comprehensive genomic profiling in small cell lung cancer management. Ariel Lopez-Chavez, MD, medical oncologist, director of precision medicine and developmental therapeutics at Allegheny Health Network Cancer Institute, discusses comprehensive genomic profiling and how it impacts the treatment and clinical management of patients with small cell lung cancer. He starts by stating that comprehensive genomic profiling in small cell lung cancer management is primarily used for patients who have never smoked, either at diagnosis or when the diagnosis of SCLC is uncertain (e.g., to differentiate it from large cell carcinoma). He also suggests its utility upon relapse to identify potential alternative therapies. "The other option would be, once patients relapse, they may…...

10+ mon, 1+ week ago (683+ words) In an interview with Peers & Perspectives in Oncology, Michael S. Leapman, MD, MHS, discusses the significance of a 10-year rise in active surveillance and watchful waiting in patients with intermediate-risk prostate cancer. Associate Professor of Urology, Yale School of Medicine Clinical Program Leader, Prostate & Urologic Cancers Program PATIENTS DIAGNOSED WITH intermediate-risk prostate cancer are increasingly likely to be managed with active surveillance or watchful waiting rather than immediate treatment, based on a recent analysis published in JAMA. In this patient population, the decision to treat or observe patients is challenging and can vary widely across the United States. Michael S. Leapman, MD, MHS, senior author and associate professor at Yale School of Medicine, discussed his takeaways from the study results and possible explanations for this trend in an interview with Peers & Perspectives in Oncology. Peers & Perspectives in Oncology: Could you describe your…...

7+ mon, 3+ day ago (504+ words) Antibody-drug conjugates continue to show benefits in breast cancer, plus the FDA has fast-tracked an innovative AI tool to help identify pancreatic tumors. Antibody-drug conjugates continue to show benefits in breast cancer, plus the FDA has fast-tracked an innovative AI tool to help identify pancreatic tumors. While overall survival (OS) data was not yet mature at the time of the analysis, an early positive trend was noted in the T-DXd combination arm. The safety profile of the T-DXd/pertuzumab combination was consistent with the known profiles of each therapy alone. Hear more from Jeff Auletta, MD, senior vice president of health equity at the National Marrow Donor Program and chief scientific officer of the Center for International Blood and Marrow Transplant Research, here. IDEAYA Biosciences has planned a phase 3 clinical trial to evaluate darovasertib as a neoadjuvant therapy for primary…...

5+ mon, 2+ week ago (109+ words) Catch up on the week's latest oncology news, from clinical trial updates to FDA approvals. This week in oncology has been marked by significant strides in targeted therapies, a re-evaluation of established treatment paradigms, and compelling evidence for the impact of lifestyle interventions. From new FDA approvals to updated clinical trial results, the landscape of cancer care continues to evolve, offering new hope and improved strategies for patients. The Targeted Pulse: A Weekly Dose of Oncology Updates This week in oncology highlights: FDA approvals and long-term study results, showcasing advancements in cancer treatments, and patient care strategies. The Targeted Pulse: Key Approvals, Regulatory Shifts, and ASCO Highlights...

9+ mon, 4+ week ago (645+ words) Daniel Rubin, PharmD, BCOP, discussed a study showing how a clinical decision support tool can improve the documentation of biomarker results in cancer care. Daniel Rubin, PharmD, BCOP A clinical decision support (CDS) tool can be optimized to improve the documentation of crucial biomarker results in cancer care, specifically for adjuvant and metastatic non'small cell lung cancer (NSCLC) and metastatic castration-resistant prostate cancer (mCRPC), according to a study by Daniel Rubin, PharmD, BCOP, McKesson.1 This approach led to significant improvements. In NSCLC, the percentage of documented known biomarkers increased substantially, from 69% to nearly 78%. Similar improvements were observed in mCRPC, where known biomarkers increased from 34% to 61%. These findings show the importance of tailoring CDS tools to the specific nuances of each cancer type. The researchers plan to implement these adjustments across a broader range of cancer types within the CDS tool....

11+ mon, 1+ week ago (668+ words) Key 2024 SABCS and ASH findings: palbociclib improves PFS in HR+, HER2+ breast cancer, cilta-cel achieves 100% CR in smoldering MM, and selinexor with ruxolitinib aids myelofibrosis. Palbociclib Plus SOC Significantly Improved PFS in HR+, HER2+ Breast Cancer First-line treatment with palbociclib (Ibrance) combined with standard-of-care therapy demonstrated a significant improvement in progression-free survival for patients with hormone receptor'positive, HER2-positive metastatic breast cancer. These results from the open-label, phase 3 AFT-38 PATINA trial (NCT02947685) were presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) by Otto Metzger, MD, of Dana-Farber Cancer Institute, Boston, Massachusetts. "Our results reinforce the strong scientific rationale for overcoming resistance to anti-HER2 therapy and endocrine therapy with the addition of palbociclib," Metzger explained. "There is a strong rationale for blocking CDK4/6 in HER2-positive disease. The cyclin D1-CDK4 axis is essential for initiation and maintenance of growth in HER2-positive disease. The same axis drives resistance…...