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Showing 1 - 50FDA Approves Datopotamab Deruxtecan-dlnk for Advanced HR-Positive, HER2-Negative Breast Cancer
On January 17, the U.S. Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk (Datroway), a TROP-2–directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC1+, or...
LIBRETTO-431 Trial Shows Selpercatinib Is Effective in East Asian Patients With RET Fusion–Positive Non–Small Cell Lung Cancer
A subgroup analysis of data from the LIBRETTO-431 trial (ClinicalTrials.gov identifier NCT04194944) showed that the selective RET inhibitor selpercatinib safely improved progression-free survival compared to chemotherapy plus pembrolizumab in East Asian patients diagnosed with RET fusion–positive...
Selpercatinib in East Asian Patients With RET Fusion–Positive NSCLC: LIBRETTO-431
Lung cancer is the leading cause of cancer-related death worldwide, accounting for the highest mortality rates among both men and women. Most lung cancers—between 80% and 85%—are non–small cell lung cancer (NSCLC), and between 1% and 2% of patients are diagnosed with RET-altered NSCLC. The results...
Advanced Unresectable Hepatocellular Carcinoma
This is Part 1 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of advanced unresectable...
Adjuvant Use of Alectinib in ALK-Positive NSCLC
On April 18, 2024, the ALK inhibitor alectinib was approved by the U.S. Food and Drug Administration (FDA) for adjuvant treatment after tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.1 Supporting Efficacy Data Approval was based ...
Inotuzumab Ozogamicin for Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia
On March 6, 2024, inotuzumab ozogamicin (Besponsa) was approved for pediatric patients aged 1 year or older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.1 Supporting Efficacy Data Approval was based on findings in the ITCC-059 trial (ClinicalTrials.gov...
FDA Approves Tislelizumab for Previously Treated Patients With Advanced Esophageal Cancer
On March 14, the U.S. Food and Drug Administration (FDA) approved the humanized immunoglobulin G4 anti–PD-1 monoclonal antibody tislelizumab-jsgr (Tevimbra) as monotherapy for adults with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not...
Bosutinib in Pediatric Chronic Myeloid Leukemia
On September 26, 2023, bosutinib (Bosulif) was approved for pediatric patients aged 1 year and older with chronic-phase Philadelphia chromosome–positive chronic myeloid leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy.1 New capsule dosage form strengths of 50 mg...
NUC-1031/Cisplatin Fails to Improve Outcomes in Advanced Biliary Tract Cancer
As a first-line treatment for advanced biliary tract cancer, an experimental formulation of gemcitabine, NUC-1031, given with cisplatin failed to improve outcomes over standard gemcitabine/cisplatin in the global phase III NuTide:121 trial.1 “NuTide:121 has not advanced the field in biliary tract...
Camrelizumab Plus Rivoceranib vs Sorafenib in Unresectable Hepatocellular Carcinoma
In a largely Asian phase III study (CARES-310) reported in The Lancet, Qin et al found that the combination of camrelizumab and rivoceranib (also known as apatinib) significantly prolonged progression-free and overall survival vs sorafenib in the first-line treatment of unresectable or metastatic...
INDIGO Trial: IDH Inhibitor Improves Progression-Free Survival in Grade 2 IDH1/2-Mutated Gliomas
The oral IDH1/2 inhibitor vorasidenib significantly improved progression-free survival in patients with grade 2 gliomas expressing IDH1/2 mutations in the phase III INDIGO trial. These results, which were reported by lead author Ingo K. Mellinghoff, MD, FACP, of Memorial Sloan Kettering Cancer...
E. John Wherry, PhD, Recognized With the 2023 AACR–Cancer Research Institute Lloyd J. Old Award in Cancer Immunology
The American Association for Cancer Research (AACR) awarded E. John Wherry, PhD, with the 2023 AACR–Cancer Research Institute Lloyd J. Old Award in Cancer Immunology during the AACR Annual Meeting in April in Orlando, Florida. Dr. Wherry is Chair of the Department of Systems Pharmacology and...
Neoadjuvant Plus Adjuvant vs Adjuvant Pembrolizumab in Advanced Melanoma
In the phase II SWOG Cancer Research Network S1801 trial reported in The New England Journal of Medicine, Sapna P. Patel, MD, and colleagues found that neoadjuvant plus adjuvant pembrolizumab significantly improved event-free survival vs adjuvant pembrolizumab alone in patients with stage IIIB to...
Common Immune-Related Adverse Events: Spotlight on Gastrointestinal and Hepatic Toxicities
At the inaugural MD Anderson Clinical Education Symposium on Immunotherapy Organ Toxicity Management (IOTOX), a panel of experts discussed common immune-related adverse events associated with immune checkpoint inhibitor therapy, including gastrointestinal (GI), hepatic, dermatologic, pulmonary, and ...
Sotorasib: A New Standard of Care for Second- or Third-Line Treatment of KRAS G12C–Mutated NSCLC?
The KRAS G12C inhibitor sotorasib doubled the rate of progression-free survival at 12 months and reduced the risk of disease progression or death by 34% compared with standard second-line docetaxel for patients with previously treated non–small cell lung cancer (NSCLC) and KRAS G12C mutations....
Sotorasib: A New Standard of Care for Second- or Third-Line Treatment of KRAS G12C–Mutated NSCLC?
The KRAS G12C inhibitor sotorasib doubled the rate of progression-free survival at 12 months and reduced the risk of disease progression or death by 34% compared with standard second-line docetaxel for patients with previously treated non–small cell lung cancer (NSCLC) and KRAS G12C mutations....
Addition of Transarterial Chemoembolization to Lenvatinib in First-Line Treatment of Advanced Hepatocellular Carcinoma
An interim analysis of the Chinese phase III LAUNCH trial was reported in the Journal of Clinical Oncology by Peng et al. The researchers found that the addition of transarterial chemoembolization to lenvatinib improved overall survival in patients with advanced hepatocellular carcinoma who were...
Adagrasib in Previously Treated Patients With KRAS G12C–Mutated Advanced NSCLC
As reported in The New England Journal of Medicine by Pasi A. Jänne, MD, PhD, and colleagues, findings in a phase II cohort of the multicohort KRYSTAL-1 phase I/II study indicate that the KRAS G12C inhibitor adagrasib showed activity in previously treated patients with unresectable or metastatic...
Mount Sinai Researcher Receives Award From the American Association of Indian Scientists in Cancer Research
Nina Bhardwaj, MD, PhD, Director of Immunotherapy at The Tisch Cancer Institute at Mount Sinai, has received the 2022 Lifetime Achievement in Cancer Research award from the American Association of Indian Scientists in Cancer Research (AAISCR). Dr. Bhardwaj is also Medical Director of the Vaccine...
SBRT in Combination With Pembrolizumab/Trametinib vs Gemcitabine in Locally Recurrent Pancreatic Cancer
In a Chinese single-institution phase II trial reported in The Lancet Oncology, Zhu et al found that stereotactic body radiotherapy (SBRT) followed by pembrolizumab plus trametinib improved overall survival vs SBRT followed by gemcitabine in patients with postresection, KRAS-mutant, PD-L1–positive...
Atezolizumab in Adjuvant Therapy for PD-L1–Positive NSCLC
On October 15, 2021, atezolizumab was approved for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells, as determined by a U.S. Food and Drug Administration...
Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
On November 17, 2021, the immunotherapeutic agent pembrolizumab was granted approval for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.1 Supporting Efficacy Data...
ALK Inhibition for Pediatric Patients With Advanced ALK-Positive Malignancies
In a phase I dose-escalation and dose-expansion study reported in The Lancet Oncology, Fischer et al found that the ALK inhibitor ceritinib produced durable responses in pediatric patients with relapsed or refractory, locally advanced or metastatic ALK-positive malignancies. Study Details In the...
Cancer Researcher and Drug Developer, Joseph R. Bertino, MD, Dies at 91
Over the arc of his notable career, Joseph R. Bertino, MD, garnered many honors for his scientific contributions leading to curative treatments for leukemia and lymphoma, such as ASCO’s David A. Karnofsky Award. Yet his legacy was perhaps most prominently punctuated by the multitude of patients...
Liver Biopsy for Evaluation of Hepatitis Associated With Immunotherapy
In a retrospective cohort study reported in a research letter in JAMA Oncology, Li et al found that the performance of liver biopsy in patients with grade ≥ 3 alanine aminotransferase (ALT) elevations during immune checkpoint inhibitor therapy was associated with a delayed start of corticosteroid...
Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...
AACR Announces Recipients of 2021 Scientific Achievement Awards and Lectureships
The American Association for Cancer Research (AACR) honored a number of cancer researchers, physician-scientists, advocates, and policymakers for their achievements during week 1 of the virtual AACR Annual Meeting 2021 (April 10–15, 2021). Several of these recipients were mentioned in previous...
Maintenance Rucaparib in Patients With Platinum-Sensitive Pancreatic Cancer and Germline or Somatic BRCA1, BRCA2, or PALB2 Variants
In a single-institution phase II study reported in the Journal of Clinical Oncology, Kim A. Reiss, MD, and colleagues found that maintenance treatment with the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib produced responses and was associated with good progression-free survival in...
Frederick W. Alt, PhD, Honored With 2021 AACR Award for Lifetime Achievement in Cancer Research
The American Association for Cancer Research (AACR) is recognizing geneticist Frederick W. Alt, PhD, with the 18th AACR Award for Lifetime Achievement in Cancer Research. Dr. Alt is a Howard Hughes Medical Institute investigator, Director of the Program in Cellular and Molecular Medicine at Boston ...
Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma
On February 5, 2021, umbralisib was granted accelerated approval for the following indications: adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti–CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have...
Nivolumab Plus Cabozantinib as First-Line Treatment of Advanced Renal Cell Carcinoma
On January 22, 2021, the U.S. Food and Drug Administration approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma.1-3 Supporting Efficacy Data Approval was based on the findings of the phase III, open-label CheckMate 9ER trial...
Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations
On February 3, 2021, tepotinib was granted accelerated approval for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.1,2 Supporting Efficacy Data Approval was supported by findings from the...
Continued Progression-Free and Overall Survival Superiority of First-Line Pembrolizumab/Axitinib vs Sunitinib
As reported in The Lancet Oncology by Thomas Powles, MD, of Barts Cancer Institute, London, and colleagues, extended follow-up of the phase III KEYNOTE-426 trial shows continued progression-free and overall survival superiority with pembrolizumab/axitinib vs sunitinib alone in first-line treatment ...
FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer
On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1...
Nivolumab Plus Ipilimumab for Metastatic Uveal Melanoma
In a single-institution phase II trial reported in the Journal of Clinical Oncology, Pelster et al found that nivolumab plus ipilimumab produced durable responses and improved survival outcomes in patients with metastatic uveal melanoma. Study Details The trial enrolled 35 patients at The...
Selpercatinib Shows Activity in RET Fusion–Positive NSCLC and RET-Altered Thyroid Cancer
As reported inThe New England Journal of Medicine by Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues and by Lori J. Wirth, MD, of Massachusetts General Hospital, and colleagues, the phase I/II LIBRETTO-001 trial has shown marked activity of the RET kinase ...
Extended Follow-up of KEYNOTE-426: First-Line Pembrolizumab/Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma
As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, extended follow-up of the phase III KEYNOTE-426 trial shows continued progression-free and overall survival superiority with pembrolizumab/axitinib vs sunitinib in the first-line treatment of advanced renal cell...
Activity of the KRAS G12C Inhibitor Sotorasib in KRAS G12C–Mutant Advanced Solid Tumors
As reported inThe New England Journal of Medicine by David S. Hong, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues, a phase I trial (CodeBreak 100) has shown activity of the oral KRAS G12C inhibitor sotorasib in heavily pretreated patients with KRAS G12C–mutant...
Addition of Atezolizumab to T-DM1 in Previously Treated Patients With HER2-Positive Advanced Breast Cancer
In the phase II KATE2 trial reported in The Lancet Oncology, Leisha A. Emens, MD, and colleagues found that the addition of atezolizumab to ado-trastuzumab emtansine (T-DM1) did not improve progression-free survival in patients with advanced HER2-positive breast cancer progressing after previous...
Pralsetinib for NSCLC With RET Gene Fusions
On September 4, 2020, pralsetinib (Gavreto) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for treatment of adults with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.1,2 The FDA simultaneously approved the...
Rucaparib Produces Durable Responses in Previously Treated Metastatic Castration-Resistant Prostate Cancer
As reported in the Journal of Clinical Oncology by Wassim Abida, MD, PhD, of Memorial Sloan Kettering Cancer Center, and colleagues, the phase II TRITON2 trial has shown that the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib produced durable responses in patients with previously treated...
Tucatinib Combination Extends Survival in HER2-Positive Metastatic Breast Cancer, Including Patients With Brain Metastases
For patients with progressing HER2-positive metastatic breast cancer previously treated with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1), no single regimen is an established standard of care. More than 50% of these patients will develop brain metastasis, and thus far, treatments...
Activity of the KRAS G12C Inhibitor Sotorasib in KRAS p.G12C–Mutant Advanced Solid Tumors
As reported in The New England Journal of Medicine by David S. Hong, MD, and colleagues, the phase I CodeBreaK100 trial showed activity of the oral KRAS G12C inhibitor sotorasib in heavily pretreated patients with KRAS p.G12C–mutant advanced non–small cell lung cancer (NSCLC), colorectal cancer,...
Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF V600–Positive Unresectable or Metastatic Melanoma
On July 30, 2020, atezolizumab was granted approval for use in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation–positive unresectable or metastatic melanoma.1,2 Supporting Efficacy Data Approval was based on findings from the phase III, double-blind IMspire150 trial ...
Rucaparib in Metastatic Castration-Resistant Prostate Cancer With Deleterious BRCA Alterations
As reported in the Journal of Clinical Oncology by Abida and colleagues, the phase II TRITON2 trial has shown that rucaparib produces durable responses in patients with metastatic castration-resistant prostate cancer with deleterious BRCA1 or BRCA2 alterations. The trial supported the May 2020...
Atezolizumab as First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression and No EGFR or ALK Aberrations
On May 18, 2020, atezolizumab was approved for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations. High PD-L1 expression is defined as PD-L1 staining of at least 50% of...
Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 15, 2020, rucaparib was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and taxane-based chemotherapy.1,2...
Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation
On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected...
Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions
On may 8, 2020, selpercatinib was granted accelerated approval for the following indications: Adult patients with metastatic RET fusion-positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who...
Tucatinib in Previously Treated HER2-Positive Metastatic Breast Cancer
On April 17, 2020, tucatinib was approved for use in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. These patients included those with brain metastases and those who have received one or more prior...
