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In the phase II ATEMPT trial reported in the Journal of Clinical Oncology, Sara M. Tolaney, MD, MPH, and colleagues found that adjuvant trastuzumab emtansine (T-DM1) resulted in “excellent” invasive disease–free survival but did not reduce clinically relevant toxicity compared with...
In an analysis from the phase III IMbrave150 trial reported in The Lancet Oncology, Peter R. Galle, MD, and colleagues found that patients receiving atezolizumab plus bevacizumab had better patient-reported outcomes vs those receiving sorafenib for advanced unresectable or metastatic hepatocellular ...
In recent years, immune checkpoint inhibitors in the treatment of mesothelioma have been a keen area of investigation for this immunogenic solid tumor. With recent publications, principally findings from CheckMate 743 by Baas et al1 (reviewed in this issue of The ASCO Post), combination immune...
As reported in The Lancet by Paul Baas, MD, of The Netherlands Cancer Institute, Amsterdam, and colleagues, a prespecified interim analysis in the phase III CheckMate 743 trial has shown improved overall survival with first-line nivolumab/ipilimumab vs platinum-based chemotherapy in unresectable...
In a letter recently published in The New England Journal of Medicine and reviewed in this issue of The ASCO Post, Rousseau and colleagues reported data on the spectrum of benefit from immune checkpoint blockade in hypermutated tumors.1 Indeed, the U.S. Food and Drug Administration (FDA) recently...
In a letter to the editor in The New England Journal of Medicine, Benoit Rousseau, MD, PhD, and Michael B. Foote, MD, of Memorial Sloan Kettering Cancer Center (MSK), and colleagues presented evidence that a high tumor mutational burden (TMB) threshold of 10 alone may not be sufficient to predict...
The pace of clinical research in metastatic renal cell carcinoma is faster than ever. Over the past 5 years, we have seen data from six phase III clinical trials evaluating combination strategies with checkpoint inhibitors. The era began with data from CheckMate 214, evaluating nivolumab with...
Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...
Cathy Eng, MD, of Vanderbilt-Ingram Cancer Center, discusses two abstracts from a session she co-chaired: the phase II DEEPER trial, which explored the use of FOLFOXIRI plus cetuximab vs FOLFOXIRI plus bevacizumab as first-line treatment in metastatic colorectal cancer with RAS wild-type tumors; and the phase II FIRE-4.5 study, which investigated FOLFOXIRI plus either bevacizumab or cetuximab as first-line treatment of BRAF V600E–mutant advanced disease (Abstracts 3501 and 3502).
Thierry André, MD, of Hôpital Saint-Antoine, discusses final overall survival data for the phase III KEYNOTE-177 study, which confirmed pembrolizumab as a new standard of care for first-line treatment of patients with microsatellite instability–high/mismatch repair–deficient metastatic colorectal cancer (Abstract 3500).
Nadia Harbeck, MD, PhD, of Ludwig Maximilian University of Munich, discusses results from the ADAPT HR–/HER2+ trial, which showed, for the first time, improved pathologic complete response and survival in patients with early breast cancer who were treated weekly with a de-escalated 12-week regimen of neoadjuvant paclitaxel plus pertuzumab and trastuzumab (Abstract 503).
As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous daratumumab to pomalidomide/dexamethasone in patients with previously treated multiple myeloma....
As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, the phase III KEYNOTE-361 trial has shown no significant improvement in progression-free or overall survival with first-line pembrolizumab plus platinum-based chemotherapy vs chemotherapy alone in patients with advanced...
As reported in The New England Journal of Medicine by Dean F. Bajorin, MD, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo among all patients with high-risk muscle-invasive urothelial carcinoma who...
In a presentation of real-world data given during the 2021 ASCO Annual Meeting, Miron et al concluded that the choice of first-line platinum chemotherapy did not result in a significant difference in overall survival benefit among patients with advanced bladder cancer who were able to go on to...
The first overall survival analysis of the WSG-ADAPT HR-/HER2+ study, which evaluated neoadjuvant therapy in patients with hormone receptor (HR)-negative, HER2-positive breast cancer, showed that treatment with pertuzumab and trastuzumab plus paclitaxel—or the chemotherapy-free regimen of...
Omid Hamid, MD, Chief of Translational Research/Immuno-Oncology at The Angeles Clinic & Research Institute, Los Angeles, and Co-Director of the Cutaneous Malignancy Program at Cedars-Sinai Cancer Institute, shared his thoughts on the RELATIVITY-047 study1 for The ASCO Post, referring to them as ...
Immune checkpoint inhibition has been established as an effective treatment for patients with metastatic melanoma. A novel immunotherapeutic combination—this one targeting the LAG-3 (lymphocyte-activation gene 3) and PD-1 immune checkpoints—delayed time to disease progression significantly more...
Brian I. Rini, MD, of Vanderbilt University, discusses findings from KEYNOTE-426, the longest follow-up of a checkpoint inhibitor (pembrolizumab) combined with a VEGF/VEGFR inhibitor (axitinib) for first-line clear cell renal cell carcinoma. The trial results continue to support this combination as a standard of care for patients with previously untreated disease (Abstract 4500).
A large retrospective study of real-world patients with renal cell carcinoma (RCC) showed similar survival outcomes for patients with intermediate- or poor-risk disease regardless of whether they were treated with the combination of axitinib plus pembrolizumab or ipilimumab plus nivolumab. These...
Patients with high-risk melanoma who had a course of pembrolizumab had longer recurrence-free survival than patients who received either ipilimumab or high-dose interferon after surgery. These findings of a large SWOG Cancer Research Network clinical trial, S1404, were presented by Grossmann et al...
Immunotherapy following surgery significantly improved disease-free survival compared to placebo among patients with high-risk clear cell renal cell carcinoma (RCC), according to results from the international phase III KEYNOTE-564 study presented at the 2021 ASCO Annual Meeting by Toni K....
The first results from the phase III CheckMate 648 study represent significant progress in the treatment of patients with advanced esophageal squamous cell carcinoma. The trial evaluated first-line treatment with nivolumab plus chemotherapy or nivolumab plus ipilimumab in patients with advanced...
In the longest follow-up results from a clinical trial of combination immunotherapy for metastatic melanoma, investigators report that nearly half the patients who received the drugs nivolumab and ipilimumab were alive at a median of 6.5 years after treatment. These long-term results from the...
Byoung Chul Cho, MD, PhD, of the Yonsei Cancer Center, discusses study results that showed treatment with the EGFR-MET bispecific antibody amivantamab plus the EGFR inhibitor lazertinib yielded responses in 36% of chemotherapy-naive patients with non–small cell lung cancer whose disease progressed on osimertinib. Genetic biomarkers may be able to identify patients most likely to benefit from the combination regimen (Abstract 9006).
Pasi A. Janne, MD, PhD, of Dana-Farber Cancer Institute, discusses study findings that show patritumab deruxtecan is effective in patients with EGFR-mutated and inhibitor-resistant non–small cell lung cancer. Dr. Janne also explains why targeting HER3, a mutation expressed in most EGFR-altered cancers, is a beneficial treatment approach (Abstract 9007).
Ian Chau, MD, of Royal Marsden NHS Foundation Trust, discusses first results of the CheckMate 648 study, which showed that nivolumab plus chemotherapy and nivolumab plus ipilimumab both demonstrated superior overall survival vs chemotherapy alone in patients with advanced esophageal squamous cell carcinoma. These regimens may represent potential new first-line treatment options (Abstract 4001).
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses phase III results from KEYNOTE-564, which evaluated the safety and efficacy of pembrolizumab in the adjuvant treatment of patients with renal cell carcinoma who have undergone nephrectomy for intermediate-high or high-risk disease or no evidence of disease (Abstract LBA5).
According to the results from the phase III JUPITER-02 study, the addition of toripalimab, a humanized IgG4K anti–PD-1 monoclonal antibody, to standard gemcitabine/cisplatin chemotherapy as first-line treatment for patients with advanced nasopharyngeal carcinoma provided superior progression-free...
The combination of ponatinib and blinatumomab was found to be safe and highly effective in patients with newly diagnosed or relapsed/refractory Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). The study—presented by Nicholas J. Short, MD, and colleagues during the 2021 ASCO...
Results from the phase II MyPathway basket trial found that the HER2-targeted therapies pertuzumab and trastuzumab demonstrated durable activity in patients with a wide variety of tumors marked by HER2 amplification or overexpression, although responses were limited in those with KRAS mutations....
As reported in the Journal of Clinical Oncology by Roisin M. Connolly, MD, and colleagues, updated results of the phase II TBCRC026 trial indicate an association of early F-18 fluorodeoxyglucose positron-emission tomography/computed tomography (F-18 FDG PET/CT) maximum standardized uptake value...
In a real-world retrospective propensity-matched cohort study reported in JAMA Network Open, Chakiryan et al found that both first-line immunotherapy and combined treatment with targeted therapy plus immunotherapy were associated with improved overall survival vs targeted therapy alone in patients...
As reported in The Lancet Oncology by Arjun V. Balar, MD, and colleagues, the phase II KEYNOTE-057 trial showed that pembrolizumab produced enduring responses in a cohort of patients with high-risk non–muscle invasive bladder cancer unresponsive to bacillus Calmette-Guérin (BCG) who were ineligible ...
As reported in the Journal of Clinical Oncology by Jonathan E. Rosenberg, MD, and colleagues, the phase III CALGB 90601/Alliance trial has shown no improvement in overall survival with the addition of bevacizumab to gemcitabine/cisplatin in patients with metastatic urothelial carcinoma. Study...
In a single-center phase II trial reported in The Lancet Oncology, Nasser K. Altorki, MD, and colleagues found that neoadjuvant durvalumab plus stereotactic body radiotherapy (SBRT) resulted in a markedly higher major pathologic response rate vs durvalumab alone in patients with early-stage...
On February 5, 2021, lisocabtagene maraleucel was approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from...
Evan J. Lipson, MD, of Johns Hopkins University, discusses primary phase III results from the RELATIVITY-047 study, which showed that relatlimab plus nivolumab as a fixed-dose combination may improve progression-free survival compared with nivolumab monotherapy in patients with advanced melanoma. This is the first study to demonstrate a benefit from dual inhibition of the LAG-3 and PD-1 pathways.
As reported in The Lancet Oncology by Stratigos et al, findings in a subgroup of a phase II trial have shown that the PD-1 antibody cemiplimab-rwlc produces enduring responses in patients with locally advanced basal cell carcinoma who had progressive disease on or intolerance to prior hedgehog...
In a study reported in JCO Oncology Practice, Khaki et al found that although the use of anticancer systemic therapy during the last 30 days of life in patients with cancer has decreased overall since the first approval of a PD-1 immune checkpoint inhibitor, the use of PD-1 or PD-L1 inhibitors...
Adding sintilimab to a regimen of gemcitabine and platinum demonstrated clinical benefit over gemcitabine and platinum alone as first-line therapy in patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). These results from the ORIENT-12 trial were published by...
On March 26, 2021, idecabtagene vicleucel was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1,2 Idecabtagene vicleucel is...
As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, of Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and colleagues, the phase III CheckMate 9ER trial has shown that the combination of nivolumab and cabozantinib improved progression-free survival and...
On January 15, 2021, the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki was approved for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.1,2 Supporting Efficacy Data...
In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...
As reported in The Lancet Oncology by Evan Y. Yu, MD, and colleagues, findings in a cohort of the phase II EV-201 study showed a high response rate with the nectin-4–directed antibody-drug conjugate enfortumab vedotin-ejfv in cisplatin-ineligible patients with advanced or metastatic urothelial...
In a retrospective cohort study reported in The Lancet Oncology, da Silva et al found that better outcomes were achieved with the combination of an anti–PD-1 agent plus ipilimumab vs ipilimumab alone in patients with advanced melanoma who were resistant to prior anti–PD-1 or anti–PD-L1 ...
On May 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. CheckMate 577 Efficacy was evaluated in CheckMate ...
In a cohort of a phase II trial reported in The Lancet Oncology, Assuntina G. Sacco, MD, and colleagues found that the combination of pembrolizumab and cetuximab produced durable responses in patients with recurrent or metastatic head and neck squamous cell carcinoma who had received no prior PD-1, ...
Heather A. Wakelee, MD, of Stanford University Medical Center, discusses the primary disease-free survival results of IMpower010, a phase III study that compared adjuvant atezolizumab vs best supportive care after adjuvant chemotherapy in patients with early-stage resected non–small cell lung cancer (Abstract 8500).