“KRAS G12C inhibitors as monotherapy yield a relatively low overall response rate, but when you combine them with an EGFR [epidermal growth factor receptor] inhibitor, the response rate is nearly double,” said Federica Di Nicolantonio, MD, PhD, Professor of Oncology at the University of Turin in...
Adagrasib, a covalent inhibitor of KRAS G12C, combined with cetuximab, showed activity in patients with metastatic colorectal cancer in the phase I/II KRYSTAL-1 trial, as presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2021 by Jared Weiss, MD,...
A 22-gene genomic classifier (the Decipher score) may be able to predict the course of disease in men with high-risk prostate cancer, according to a patient-level meta-analysis of three randomized clinical trials presented by Paul L. Nguyen, MD, at the 2021 American Society for Radiation Oncology...
On October 22, Oncopeptides announced its decision to withdraw melphalan flufenamide (Pepaxto), a first-in-class peptide-drug conjugate, from the market in the United States, following results from the phase III OCEAN study in patients with relapsed or refractory multiple myeloma. The decision to...
On September 22, 2021, ruxolitinib, a tyrosine kinase inhibitor of JAK1 and JAK2 was granted approval for treatment of chronic graft-vs-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged ≥ 12 years.1 Supporting Efficacy Data Approval was...
As reported in the Journal of Clinical Oncology by John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, and colleagues, the phase III ELEVATE-RR trial has shown noninferior progression-free survival with the more-selective Bruton’s tyrosine kinase (BTK) inhibitor...
On September 17, 2021, cabozantinib was approved for adult and pediatric patients aged ≥ 12 years with locally advanced or metastatic differentiated thyroid cancer progressing after VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.1 Cabozantinib inhibits the...
Study discussant Bruna Pellini, MD, of the Department of Thoracic Oncology, Moffitt Cancer Center, Florida, noted that, regardless of PD-L1 or tumor mutation burden status, the NADIM trial demonstrated improved progression-free and overall survival for patients with resectable, stage IIIA non–small ...
The combination of dual checkpoint inhibition plus chemotherapy could be the new standard of care in first-line metastatic non–small cell lung cancer (NSCLC), according to data presented during the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer.1 ...
Invited discussant Eleni Efstathiou, MD, of Houston Methodist Cancer Center and Athens Medical Center, Greece, said that both the STAMPEDE meta-analysis1 and the PEACE-1 trial2 firmly establish the importance of introducing abiraterone acetate earlier in the course of treatment. “The STAMPEDE...
Hope S. Rugo, MD, of the University of California, San Francisco, discusses phase III results from the KEYNOTE-355 study of pembrolizumab plus chemotherapy, which improved overall survival vs chemotherapy alone in patients with previously untreated locally recurrent, inoperable, or metastatic...
The addition of 2 years of abiraterone acetate plus prednisolone (AAP) to androgen-deprivation therapy improves metastasis-free survival and overall survival compared with androgen-deprivation therapy alone in men with nonmetastatic castration-sensitive prostate cancer, according to a primary...
Florian Lordick, MD, PhD, Professor of Oncology and Director of the University Cancer Center Leipzig, Germany, applauded the positive finding for nivolumab plus chemotherapy in CheckMate 6491 and questioned why nivolumab plus ipilimumab did not meet its endpoint. “I’m calling this a big step...
Longer follow-up data from the phase III CheckMate 649 trial support the use of nivolumab plus chemotherapy as a new standard first-line regimen in patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The findings were reported by Yelena Janjigian, ...
Commenting on the SECOMBIT trial was Omid Hamid, MD, Chief of Translational Research and Immunotherapy at The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate, and Co-Director, Cutaneous Malignancy Program, Cedars-Sinai Cancer. Dr. Hamid said SECOMBIT addresses an important...
Barbara Pistilli, MD, of the Breast Cancer Group at Gustave Roussy Cancer Center, Villejuif, France, said the results of the TULIP trial, showing the progression-free survival benefit for vic-trastuzumab duocarmazine (SYD985), help to establish antibody-drug conjugates as key components of the...
In the global phase III TULIP trial in metastatic HER2-positive breast cancer, treatment with the antibody-drug conjugate vic-trastuzumab duocarmazine (SYD985) significantly improved progression-free survival in comparison with standard chemotherapy in previously treated patients, making this a new ...
The VESPER phase III trial answers some key questions regarding the optimal management of muscle-invasive bladder cancer. The study found that the neoadjuvant regimen of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) was superior to standard gemcitabine/cisplatin in...
The invited discussant of the MONALESSA-2 trial was Gonzalo Gomez-Abuin, MD, a medical oncologist who is Head of the Clinical Research Unit at Hospital Alemán in Buenos Aires. According to Dr. Gomez-Abuin, phase III trials of three different CDK4/6 inhibitors—ribociclib, palbociclib, and...
Ribociclib plus hormonal therapy in the first-line setting boosted overall survival by more than 1 year, vs hormone therapy alone, in postmenopausal women with hormone receptor–positive HER2-negative advanced breast cancer, according to the latest findings from the MONALEESA-2 trial, reported at...
As reported in The Lancet Oncology by Thierry Facon, MD, and colleagues, an interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to lenalidomide/dexamethasone in newly diagnosed, transplant-ineligible patients with ...
Dieter Hörsch, MD, of Germany’s Central Clinic in Bad Berka, discusses phase III results from the SPINET trial, the largest prospective study to date of the somatostatin analog lanreotide autogel. The study suggests that this agent may prove to be an appropriate treatment option for patients with...
Rechallenge with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib in patients with platinum-sensitive ovarian cancer led to significant improvement in progression-free survival, in patients with either BRCA1/2-mutated or nonmutated (ie, wild-type) disease compared with placebo, according ...
As reported in JAMA Surgery by van der Kruijssen et al, 60-day post–random assignment mortality results in the Danish/Dutch phase III CAIRO4 trial showed higher rates of mortality in patients with metastatic colorectal cancer who received primary tumor resection plus systemic treatment vs those...
As reported in the Journal of Clinical Oncology by Buske et al, the final analysis of the pivotal phase III iNNOVATE trial has shown a continued progression-free survival benefit with the addition of ibrutinib to rituximab in patients with Waldenström’s macroglobulinemia after 50 months of...
Neeraj Agarwal, MD, of Hunstman Cancer Institute at the University of Utah, discusses efficacy and safety results from the COSMIC-021 study, in which cabozantinib plus atezolizumab demonstrated clinically meaningful activity and a manageable safety profile in patients with metastatic...
In the past year, the U.S. Food and Drug Administration (FDA) approved five treatment options for patients with breast cancer, which are summarized herein. Abemaciclib Combination On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase...
Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...
EA1131 study discussant, Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, commented: “At this point, capecitabine remains preferred as...
In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...
As reported in The New England Journal of Medicine by Aditya Bardia, MD, of the Division of Medical Oncology, Massachusetts General Hospital Cancer Center, and colleagues, the phase III ASCENT trial has shown prolonged progression-free and overall survival with the Trop-2–directed antibody-drug...
The invited discussant of GeparNuevo,1 Melinda L. Telli, MD, Associate Professor of Medicine at Stanford University School of Medicine, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, welcomed the additional data...
In the phase II GeparNuevo trial, patients with early triple-negative breast cancer receiving the PD-L1 inhibitor durvalumab in addition to chemotherapy as neoadjuvant therapy saw improvements in long-term outcomes. The results were presented at the 2021 ASCO Annual Meeting by Sibylle Loibl, MD,...
Invited discussant Giuseppe Curigliano, MD, PhD, Associate Professor of Medical Oncology at the University of Milan, Italy, and Head of the Division of Early Drug Development at the European Institute of Oncology, said the “clear” findings of KEYNOTE-5221 are “practice-changing.” However, the ideal ...
The latest analysis of the phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III trial to ...
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at the 38th Miami Breast Cancer Conference, held virtually this year, by Adam M....
As reported in JAMA Oncology by Hope S. Rugo, MD, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs...
Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for recurrence. High-risk patients, however, derived considerably more...
With three new HER2-targeted therapies approved over the past year or two alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and...
The SWOG S1007 RxPONDER trial evaluated the benefit of chemotherapy in women with early-stage hormone receptor–positive, HER2-negative breast cancer and node-positive disease.1 The data showed that many postmenopausal women can skip adjuvant chemotherapy, based on a 46% reduction in the risk of...
The primary outcome analysis of the phase III monarchE trial, an update of previous data, continued to show significant benefit for abemaciclib in the adjuvant setting, reducing the risk for invasive disease recurrence by 28.7%. Meanwhile, the first results of the phase III PENELOPE-B trial of...
As reported in The Lancet Oncology by Erica L. Mayer, MD, and colleagues, the second interim analysis of the phase III PALLAS trial showed no improvement in invasive disease–free survival with the addition of adjuvant palbociclib to ongoing endocrine therapy in patients with hormone receptor...
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
Because of their well-established efficacy, inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) are the standard of care in the treatment of hormone receptor–positive, HER2-negative metastatic breast cancer. The question now is this: After disease progresses on a CDK4/6 inhibitor and endocrine...
The past decade has seen an explosion of novel agents for breast cancer across subtypes. Although each new advance improves therapeutic options for patients, it also brings forth a challenging question: Who needs what treatment? Not all cancers are created equally, and similarly not all patients...
Invited discussant of the PEACE-1 trial, Eleni Efstathiou, MD, of the Houston Methodist Cancer Center and Athens Medical Center, Greece, reminded listeners: “Androgen signaling inhibition is the prevailing therapeutic strategy in advanced prostate cancer, with reproducible outcomes. Many studies...
The addition of abiraterone acetate plus prednisone on top of androgen-deprivation therapy plus docetaxel improved survival in patients with de novo metastatic castration-sensitive prostate cancer vs androgen-deprivation therapy plus docetaxel alone. These results were from the phase III PEACE-1...
As reported in The Lancet Oncology by Fred Saad, MD, FRCS, and colleagues, the phase III ACIS trial has shown that the addition of apalutamide to abiraterone acetate and prednisone significantly prolonged radiographic progression–free survival in men with metastatic castration-resistant prostate...
The Association for Clinical Oncology (the Association) launched the ASCO Patient-Centered Cancer Care Certification, a new pilot that certifies outpatient oncology group practices and health systems that meet a single set of comprehensive, expert-backed standards for patient-centered care...
In an analysis of long-term outcomes from the phase III NRG/RTOG 9804 trial reported in the Journal of Clinical Oncology, Beryl McCormick, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that whole-breast irradiation vs observation was associated with a reduced risk of all and...