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colorectal cancer

Previously Treated Metastatic Colorectal Cancer: Lenvatinib/Pembrolizumab vs Standard of Care

As reported in the Journal of Clinical Oncology by Akihito Kawazoe, MD, and colleagues, the final analysis of  the phase III LEAP-017 trial showed no significant overall survival benefit with lenvatinib plus pembrolizumab vs the standard of care in previously treated patients with mismatch...

lung cancer

Previously Treated Metastatic NSCLC: Sacituzumab Govitecan vs Docetaxel

As reported in the Journal of Clinical Oncology by Luis G. Paz-Ares, MD, PhD, and colleagues, the phase III EVOKE-01 trial has shown a numeric but not statistically significant improvement in overall survival with sacituzumab govitecan-hziy vs docetaxel in patients with metastatic non–small cell...

lung cancer

Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations

On February 15, 2024, tepotinib (Tepmetko)-—a kinase inhibitor directed against MET, including variants with exon 14 skipping—was granted regular approval for patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping ...

gynecologic cancers

Advanced Ovarian Cancer: Adding Ruxolitinib to Front-Line Neoadjuvant Chemotherapy Plus Interval Debulking Surgery

In a phase I/II NRG Oncology Group study reported in the Journal of Clinical Oncology, Landen et al found that the addition of ruxolitinib to front-line paclitaxel/carboplatin neoadjuvant chemotherapy and interval debulking surgery improved progression-free survival in patients with stage III to IV ...

sarcoma

Doublet for Previously Treated Patients With Advanced Leiomyosarcoma

In a phase Ib study reported in the Journal of Clinical Oncology, Van Tine et al established the recommended phase II dose of oral unesbulin in combination with dacarbazine for patients with locally recurrent, unresectable or metastatic, relapsed or refractory leiomyosarcoma. Unesbulin is a small...

hepatobiliary cancer

Pembrolizumab/Chemotherapy for Advanced Biliary Tract Cancer

On October 31, 2023, pembrolizumab (Keytruda) was approved for use with ­gemcitabine/cisplatin in first-line treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on the double-blind KEYNOTE-966 trial...

kidney cancer

Belzutifan in Previously Treated Advanced Renal Cell Carcinoma

On December 14, 2023, the hypoxia-inducible factor inhibitor belzutifan (Welireg) was approved for patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma with disease progression on previous treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial...

gastroesophageal cancer

Bispecific Antibody Plus Chemotherapy Improves Survival in Patients With Gastric or Gastroesophageal Junction Cancer

Treatment with the first-in-class PD-1/CTLA-4 bispecific antibody cadonilimab plus XELOX (capecitabine, oxaliplatin) chemotherapy demonstrated a survival advantage for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma as first-line treatment, regardless of PD-L1...

breast cancer

Selective Targeting of PARP1 in Early-Phase Study Shows Activity in Breast Cancer

Saruparib, a first-in-class PARP1-­selective inhibitor, was reported to have favorable safety and anticancer activity in heavily pretreated patients with breast cancer harboring homologous recombination–repair (HRR) mutations, according to the results of the phase I/II PETRA study presented at the...

breast cancer

Dato-DXd in Advanced or Metastatic HR-Positive/HER2-Negative or Triple-Negative Breast Cancer

In the phase I TROPION-PanTumor01 trial reported in the Journal of Clinical Oncology, Aditya Bardia, MD, PhD, and colleagues found that the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) was active in patients with locally advanced or metastatic hormone receptor...

colorectal cancer

Adagrasib Plus Cetuximab: Potential Option for KRAS G12C–Mutated Colorectal Cancer

Although KRAS was once considered an untargetable mutation, KRAS inhibitors are now approved for the treatment of KRAS-mutated non–small cell lung cancer (NSCLC) and are emerging as a potential option for the treatment of KRAS G12C–mutated colorectal cancer in combination with other therapies....

lymphoma

B-Cell Non-Hodgkin Lymphoma: Extended Follow-up With Mosunetuzumab

As reported in the Journal of Clinical Oncology by L. Elizabeth Budde, MD, PhD, and colleagues, extended follow-up of the dose-escalation phase of a phase I/II trial showed that the CD20 x CD3 T-cell–engaging bispecific antibody mosunetuzumab-axgb—given as an off-the-shelf fixed-duration outpatient ...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Bispecific Immune Checkpoint Inhibitor Improves Survival in Patients With Gastric Cancer, Regardless of PD-L1 Status

The PD-1/CTLA-4 bispecific antibody cadonilimab plus chemotherapy improved progression-free and overall survival in patients with untreated, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer—including those with PD-L1–low tumors—compared with...

ASCO Congratulates 2024 Special Awards Recipients

ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care around the world with the Society’s highest honors at the 2024 ASCO Annual Meeting. The 2024 Special Award Recipients...

kidney cancer

Belzutifan in Previously Treated Advanced Renal Cell Carcinoma

On December 14, 2023, the hypoxia-inducible factor inhibitor belzutifan (Welireg) was approved for patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma with disease progression on previous treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial...

gynecologic cancers

Pembrolizumab With Chemoradiotherapy for FIGO 2014 Stage III–IVA Cervical Cancer

On January 12, 2024, pembrolizumab (Keytruda) was approved for use with chemoradiotherapy for treatment of patients with International Federation of Gynecology and Obstetrics (FIGO) 2014 stage III–IVA cervical cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind...

leukemia

FLT3-ITD–Mutated AML: Gilteritinib in Posttransplantation Maintenance

In the phase III MORPHO trial reported in the Journal of Clinical Oncology, Mark J. Levis, MD, PhD, and colleagues found that the FLT3 inhibitor gilteritinib showed activity as post–allogeneic hematopoietic cell transplantation (HCT) maintenance among patients with FLT3-ITD–mutated acute myeloid...

lung cancer

Repotrectinib for ROS1 Fusion–Positive Advanced NSCLC

On November 15, 2023, repotrectinib (Augtyro) was approved for locally advanced or metastatic ROS1 fusion–positive non–small cell lung cancer (NSCLC).1 This is the first U.S. Food and Drug Administration approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1...

skin cancer

Adjuvant Pembrolizumab in Resected Stage IIB or IIC Melanoma

As reported in the Journal of Clinical Oncology by Jason J. Luke, MD, FACP, and colleagues, the final prespecified analysis of distant metastasis–free survival in the phase III KEYNOTE-716 trial showed continued benefit with adjuvant pembrolizumab vs placebo in patients with resected stage IIB or...

prostate cancer

Localized or Advanced Prostate Cancer: Short- or Longer-Term Relugolix Plus Radiotherapy

In an analysis reported in JAMA Oncology, Daniel E. Spratt, MD, and colleagues found that treatment with relugolix was associated with rapid achievement of sustained castration in patients with localized or advanced prostate cancer who were also receiving radiotherapy. Study Details The analysis...

breast cancer

Metastatic Triple-Negative Breast Cancer: Sacituzumab Govitecan vs Single-Agent Chemotherapy in Previously Treated Patients

As reported in the Journal of Clinical Oncology by Aditya Bardia, MD, MPH, and colleagues, final results of the phase III ASCENT trial showed continued superior progression-free and overall survival with sacituzumab govitecan-hziy, an anti–trophoblast cell surface antigen 2 (Trop-2) antibody-drug...

cns cancers

Novel Monotherapy in Recurrent H3 K27M–Mutant Diffuse Midline Glioma

In an analysis reported in the Journal of Clinical Oncology, Arrillaga-Romany et al found that single-agent ONC201 (dordaviprone), a first-in-class imipridone, showed activity in recurrent histone 3 (H3) K27M-mutant diffuse midline glioma. As noted by the investigators, “H3 K27M–mutant diffuse...

breast cancer

Adjuvant Olaparib for Germline BRCA1/2-Mutant, High-Risk HER2-Negative Early Breast Cancer: Patient-Reported Outcomes From the OlympiA Trial

In a patient-reported outcomes analysis from the phase III OlympiA trial reported in the Journal of Clinical Oncology, Patricia A. Ganz, MD, FASCO, and colleagues found no clinically important differences in fatigue—the outcome of primary interest—between adjuvant olaparib and placebo in patients...

myelodysplastic syndromes

MRD Markers and Outcomes in Patients With MDS After Stem Cell Transplant

In a Scandinavian study reported in the Journal of Clinical Oncology, Tobiasson et al found that individual-patient measurable residual disease (MRD) could be assessed by next-generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) to predict outcomes in patients with...

issues in oncology
lung cancer

Sotorasib, the Poster Child for Project Optimus: Truths and Fantasies

In January 2021, two of us wrote in these pages about our field’s pressing need to pivot away from identifying and deploying the maximum tolerated dose (MTD) when it comes to targeted oncology therapies.1 We argued that, instead, one should be looking for the “optimal dose”—the dose that best...

breast cancer

Addition of Palbociclib to Letrozole in ER-Positive, HER2-Negative Advanced Breast Cancer: Overall Survival in PALOMA-2

As reported in the Journal of Clinical Oncology by Dennis J. Slamon, MD, PhD, and colleagues, the phase III PALOMA-2 trial showed no overall survival benefit with the addition of palbociclib to letrozole in patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer with no...

bladder cancer

Sacituzumab Govitecan Plus Pembrolizumab in Metastatic Urothelial Cancer Progressing After Platinum-Based Chemotherapy

In a cohort of the phase II TROPHY-U-01 trial (cohort 3) reported in the Journal of Clinical Oncology, Petros Grivas, MD, PhD, and colleagues found that the combination of sacituzumab govitecan-hziy and pembrolizumab showed activity in patients with metastatic urothelial cancer and disease...

kidney cancer

Survival Benefit With Adjuvant Immunotherapy in Patients With Clear Cell RCC

The phase III KEYNOTE-564 study has reported that adjuvant pembrolizumab provides a significant improvement in overall survival for patients with clear cell renal cell carcinoma at high risk of recurrence after surgery. This study is significant, as it represents the first phase III study to show...

prostate cancer

Cabozantinib and Atezolizumab in Metastatic Castration-Resistant Prostate Cancer

Patients with metastatic castration-resistant prostate cancer with extrapelvic nodal or visceral metastasis who were treated with the combination of cabozantinib plus atezolizumab had significantly improved time to disease progression compared with those who were treated with hormonal therapy. This ...

prostate cancer

Use of Enzalutamide in Nonmetastatic Castration-Sensitive Prostate Cancer With Biochemical Recurrence

On November 16, 2023, the androgen receptor inhibitor enzalutamide was approved for use in patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.1 Supporting Efficacy Data Approval was based on the EMBARK trial (ClinicalTrials.gov...

kidney cancer

Final Overall Survival Analysis of CLEAR/KEYNOTE-581: Lenvatinib/Pembrolizumab vs Sunitinib in First-Line Treatment of Advanced RCC

As reported in the Journal of Clinical Oncology by Robert J. Motzer, MD, and colleagues, the prespecified final overall analysis of the phase III CLEAR/KEYNOTE-581 trial supported a benefit of lenvatinib/pembrolizumab vs sunitinib in the first-line treatment of advanced renal cell carcinoma. The...

gastroesophageal cancer

Combining PD-L1 and TIGIT Inhibitors Plus Chemotherapy in Esophageal Cancer

Results from the phase III SKYSCRAPER-08 study found that combining PD-L1 and T-cell immunoglobulin and ITM domain (TIGIT) inhibitors plus chemotherapy in the first-line setting extended survival in an Asian population of patients with metastatic or locally advanced esophageal squamous cell...

lung cancer

Neoadjuvant/Adjuvant Pembrolizumab in Resectable NSCLC

On October 16, 2023, pembrolizumab was approved for use with platinum-containing chemotherapy as neoadjuvant treatment and as single-agent adjuvant treatment in patients with resectable (tumors ≥ 4 cm or node-positive) non–small cell lung cancer (NSCLC).1 Supporting Efficacy Data Approval was based ...

leukemia

Combination Treatment That Skips Chemotherapy May Be Effective for Older Patients With Philadelphia Chromosome–Positive ALL

Older patients with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) who were not candidates for the standard treatment of intensive chemotherapy had a median overall survival of 6.5 years on an alternative regimen of dasatinib and blinatumomab, according to long-term results...

lung cancer
genomics/genetics

Encorafenib Plus Binimetinib in Metastatic NSCLC With BRAF V600E Mutation

On October 11, 2023, the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) was approved for patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA...

breast cancer

Novel Targeted Therapies May Benefit Patients With Metastatic Hormone Receptor–Positive/HER2-Negative Breast Cancer

Two studies led by researchers at The University of Texas MD Anderson Cancer Center demonstrated clinical benefit from novel targeted therapies, which may offer new treatment options for patients with metastatic hormone receptor–positive/HER2-negative breast cancer. The data were shared in oral...

breast cancer

Tucatinib Plus T-DM1 May Benefit Patients With Advanced or Metastatic HER2-Positive Breast Cancer

A combination of two HER2-targeted drugs—tucatinib and ado-trastuzumab emtansine (T-DM1), extended progression-free survival among patients with unresectable, locally advanced, or metastatic HER2-positive breast cancer compared with T-DM1 alone, according to results from the HER2CLIMB-02 trial...

breast cancer

Neoadjuvant Chemotherapy May Help Some Patients With Breast Cancer Skip Regional Nodal Irradiation

For patients whose breast cancer converted from lymph node–positive to lymph node–negative disease after neoadjuvant chemotherapy, skipping adjuvant regional nodal irradiation did not increase the risk of disease recurrence or death 5 years after surgery, according to results from the NRG...

lung cancer

Adding Tiragolumab to Atezolizumab and Chemotherapy in Previously Untreated Extensive-Stage SCLC

As reported in the Journal of Clinical Oncology by Charles M. Rudin, MD, PhD, and colleagues, the phase III SKYSCRAPER-02 trial showed no progression-free or overall survival benefit with the addition of the T-cell immunoglobulin and ITM domain (TIGIT) inhibitor tiragolumab to atezolizumab and...

lung cancer

Risk-Adapted Radioimmunotherapy for Locally Advanced PD-L1–Positive NSCLC

In the phase II SPRINT trial reported in the Journal of Clinical Oncology, Ohri et al found that a chemotherapy-sparing regimen of pembrolizumab with risk-adapted radiotherapy was associated with good outcomes in patients with stage III or unresectable stage II non–small cell lung cancer (NSCLC)...

Highlights From the ESMO Congress 2023

The European Society for Medical Oncology (ESMO) Congress 2023 held in Madrid reported out several eagerly awaited and potentially practice-changing trials, bringing forward promising new combination strategies in the targeted and immunotherapy space, and put to the test selective agents against...

leukemia

Inotuzumab Ozogamicin–Based Induction in Older Patients With Philadelphia Chromosome–Negative B-Cell–Precursor ALL

In a German phase II trial (INITIAL-1) reported in the Journal of Clinical Oncology, Matthias Stelljes, MD, and colleagues found that inotuzumab ozogamicin–based induction therapy followed by age-adapted chemotherapy was associated with promising outcomes in newly diagnosed patients older than age...

prostate cancer
genomics/genetics

Outcomes With Olaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer in the PROfound Trial

In an analysis of the phase III PROfound trial reported in the Journal of Clinical Oncology, Joaquin Mateo, MD, PhD, and colleagues found that olaparib improved outcomes vs abiraterone or enzalutamide among the subgroup of patients with metastatic castration-resistant prostate cancer who had...

lung cancer

Highlights From the 2023 World Conference on Lung Cancer

The management of lung cancer and other thoracic malignancies has evolved significantly over the past decade. Thanks to many scientific advancements in the field, new therapeutic options, and improvements in screening and early detection, more patients are being cured, and many others are living...

integrative oncology

Understanding Patient Engagement in Virtual Mind-Body Therapies

Guest Editor’s Note: Virtual platforms have grown increasingly popular for health- and wellness-promoting activities. But given patients’ unique backgrounds, capabilities, interests, and goals, promoting engagement represents a complex challenge both in the context of care delivery as well as...

gynecologic cancers

Addition of First-Line Pembrolizumab to Chemotherapy, With or Without Bevacizumab, in Advanced Cervical Cancer: Final Overall Survival Results From KEYNOTE-826

In an analysis reported in the Journal of Clinical Oncology, Bradley J. Monk, MD, FACS, FACOG, and colleagues described final overall survival results from the phase III KEYNOTE-826 trial, which evaluated the addition of first-line pembrolizumab to chemotherapy, with or without bevacizumab, in...

skin cancer
immunotherapy

Major Pathologic Response to Neoadjuvant Pembrolizumab in Advanced Melanoma Trial Exceeds 50%

In exploratory analyses of results from the SWOG S1801 trial in patients with stage III to IV resectable melanoma, researchers saw a major pathologic response in more than half of surgical specimens taken from patients who had been treated with neoadjuvant pembrolizumab. These and other results of...

skin cancer

Melphalan-Based Liver-Directed Therapy for Metastatic Uveal Melanoma

On August 14, 2023, the Hepzato Kit—melphalan for injection/hepatic delivery system—was approved as a liver-directed treatment for adults with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver.1 Patients must have either no extrahepatic disease or extrahepatic ...

multiple myeloma

Accelerated Approval Granted for Use of Elranatamab-bcmm in Relapsed or Refractory Multiple Myeloma

On August 14, 2023, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager elranatamab-bcmm was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of...

breast cancer

HER3-Expressing Metastatic Breast Cancer: Patritumab Deruxtecan in Previously Treated Patients

In a Japanese-U.S. phase I/II trial (U31402-A-J101) reported in the Journal of Clinical Oncology, Ian E. Krop, MD, PhD, and colleagues found that the HER3-targeted antibody-drug conjugate patritumab deruxtecan (HER3-DXd) produced durable responses in previously treated patients with HER3-expressing ...

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