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Showing 101 - 150Sotorasib, 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...
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...
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...
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...
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 ...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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 ...
Tucatinib/Trastuzumab for Previously Treated Patients With HER2-Positive Metastatic Biliary Tract Cancer
As reported in the Journal of Clinical Oncology by Nakamura et al, findings in a cohort of the phase II SGNTUC-019 basket study showed that tucatinib plus trastuzumab was active in previously treated patients with HER2-positive metastatic biliary tract cancer who had not received prior...
ASTRO Names FASTRO Recipients for 2023
A total of 29 distinguished members of the American Society for Radiation Oncology (ASTRO) have been named Fellows of ASTRO. The ASTRO Fellow designation, FASTRO, honors individuals who have contributed significantly to the Society through committee work, other volunteer service, and to the field...
HERTHENA-Lung01: Patritumab Deruxtecan for Advanced EGFR-Mutant NSCLC
In the phase II HERTHENA-Lung01 trial reported in the Journal of Clinical Oncology, Helena Yu, MD, and colleagues found that patritumab deruxtecan (HER3-DXd), a new anti-HER3 antibody-drug conjugate, showed activity in patients with EGFR-mutated advanced non–small cell lung cancer (NSCLC)...
Tisotumab Vedotin–Based Combinations in Advanced Cervical Cancer
In a phase Ib/II study (innovaTV 205/GOG-3024/ENGOT-cx8) reported in the Journal of Clinical Oncology, Ignace B. Vergote, MD, PhD, and colleagues found that tisotumab vedotin-tftv combined with carboplatin or pembrolizumab showed activity in both treatment-naive and previously treated patients with ...
Selinexor Maintenance Therapy in Advanced or Recurrent Endometrial Cancer
In a phase III study (ENGOT-EN5/GOG-3055/SIENDO) reported in the Journal of Clinical Oncology, Ignace B. Vergote, MD, PhD, and colleagues found that a progression-free survival benefit with maintenance selinexor vs placebo after first-line chemotherapy in patients with advanced or recurrent...
Quizartinib in Newly Diagnosed FLT3-ITD–Positive Acute Myeloid Leukemia
On July 20, 2023, quizartinib was approved for use with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy in adults with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication...
Thomas J. Herzog, MD, Takes Office as President of the GOG Foundation, Inc
Thomas J. Herzog, MD, took office as President of the GOG Foundation (GOG-F, formerly the Gynecologic Oncology Group), Inc, on July 20, 2023, at the NRG Oncology Summer Meeting. Former GOG-F President, Larry J. Copeland, MD, passed the presidential gavel to Dr. Herzog at the GOG-F Board of...
Modified Citrus Pectin Treatment for Nonmetastatic Prostate Cancer
In the long-term treatment phase of an Israeli phase II study reported in the journal Nutrients, Keizman et al found that PectaSol modified citrus pectin (P-MCP) may be effective in patients with nonmetastatic, biochemically relapsed prostate cancer. As stated by the investigators, “[P-MCP] is a...
CAR T-Cell Therapies: Trends and Indications
The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. With this installment, we launch a new series of articles on commercially available chimeric antigen receptor (CAR) T-cell therapies. Syed Ali Abutalib, MD, and Jennifer N. ...
Talazoparib With Enzalutamide in HRR Gene–Mutated Metastatic Castration-Resistant Prostate Cancer
On June 20, 2023, the PARP inhibitor talazoparib was approved for use with enzalutamide in homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer.1 Supporting Efficacy Data Approval was based on findings in the multicohort, double-blind TALAPRO-2 trial...
Glofitamab-gxbm for Select Relapsed or Refractory Large B-Cell Lymphomas
On June 15, 2023, the bispecific CD20-directed CD3 T-cell engager glofitamab-gxbm was granted accelerated approval for relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma after at least two lines of...
Extended Follow-up of TROPiCS-02 Trial: Sacituzumab Govitecan in Metastatic Breast Cancer
Additional follow-up of the phase III TROPiCS-02 trial has upheld the progression-free and overall survival benefit seen with sacituzumab govitecan-hziy compared with physician’s choice of treatment in patients with endocrine-resistant, hormone receptor–positive, HER2-negative metastatic breast...
First-Line Atezolizumab vs Single-Agent Chemotherapy in Patients With Advanced NSCLC Ineligible for Platinum-Based Chemotherapy
In the phase III IPSOS trial reported in The Lancet, Lee et al found that first-line atezolizumab improved overall survival vs single-agent chemotherapy in patients with advanced non–small cell lung cancer (NSCLC) who were ineligible for platinum-based chemotherapy. Study Details In the open-label...
Incorporation of Gilteritinib Into Induction and Consolidation Chemotherapy and as Maintenance Therapy in Newly Diagnosed Patients With AML
In a phase Ib trial (2215-CL-0103) reported in the Journal of Clinical Oncology, Keith W. Pratz, MD, and colleagues found that incorporation of the FLT3 inhibitor gilteritinib into intensive induction and consolidation chemotherapy and its use as single-agent maintenance therapy were associated...
Trends in Receipt of End-of-Life Systemic Treatment for Patients With Cancer
In a U.S. study reported in the Journal of Clinical Oncology, Canavan et al found that White vs Black patients, patients with commercial insurance vs Medicare/Medicaid, and patients treated at community practices vs academic centers were more likely to receive end-of-life systemic therapy for...
Use of Zipalertinib in Previously Treated Patients With Advanced NSCLC and EGFR Exon 20 Insertions
In a phase I/IIa study reported in the Journal of Clinical Oncology, Piotrowska et al found that the EGFR tyrosine kinase inhibitor zipalertinib showed activity and an acceptable safety profile in previously treated patients with advanced non–small cell lung cancer (NSCLC) and EGFR exon 20...
Second-Line Trastuzumab, Ramucirumab, and Paclitaxel in Previously Treated Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction Cancer
In a Korean phase Ib/II trial reported in the Journal of Clinical Oncology, Kim et al found that trastuzumab combined with ramucirumab and paclitaxel showed activity in the second-line treatment of patients with HER2-positive advanced gastric or gastroesophageal junction cancer whose disease...
Intracranial Activity of Adagrasib in Patients With KRAS G12C–Mutated NSCLC and Untreated CNS Metastases
In an analysis reported in the Journal of Clinical Oncology, Negrao et al identified outcomes in the KRYSTAL-1 trial among patients with advanced KRAS G12C–mutated non–small cell lung cancer (NSCLC) who had untreated central nervous system (CNS) metastases at baseline and were treated with...
Addition of Relacorilant to Nab-paclitaxel in Recurrent, Platinum-Resistant Ovarian Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Nicoletta Colombo, MD, and colleagues found that the selective glucocorticoid receptor modulator relacorilant (given on an intermittent schedule) plus nab-paclitaxel showed benefits vs nab-paclitaxel alone in patients with recurrent, ...
First-Line Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer
As reported in the Journal of Clinical Oncology by O’Donnell et al, findings in a cohort of the phase Ib/II EV-103/KEYNOTE-869 study showed durable responses with first-line enfortumab vedotin-ejfv plus pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial...
TROP-2–Directed Antibody-Drug Conjugate Datopotamab Deruxtecan in Advanced NSCLC
In a phase I study (TROPION-PanTumor01) reported in the Journal of Clinical Oncology, Shimizu et al described outcomes with the trophoblast cell-surface antigen 2 (TROP-2)-directed antibody-drug conjugate datopotamab deruxtecan at the dose selected for further development in patients with advanced...
Long-Term Survival Outcomes With Pembrolizumab vs Ipilimumab in Advanced Melanoma: 7-Year Follow-up of KEYNOTE-006
As reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, and colleagues, the 7-year follow-up of the phase III KEYNOTE-006 trial has shown a continued overall survival benefit with pembrolizumab vs ipilimumab in patients with advanced melanoma. The primary analysis of the trial...
Pembrolizumab/Olaparib vs Next-Generation Hormonal Agents in Previously Treated Patients With Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer
As reported in the Journal of Clinical Oncology by Emmanuel S. Antonarakis, MD, and colleagues, the phase III KEYLYNK-010 trial has shown no improvement in survival outcomes with pembrolizumab/olaparib vs a next-generation hormonal agent (abiraterone or enzalutamide) in previously treated patients...
Expert Point of View: Zeynep Eroglu, MD
The formal discussant of the phase II SWOG S1512 trial was Zeynep Eroglu, MD, of the Department of Cutaneous Oncology at the Moffitt Cancer Center in Tampa, Florida. She congratulated Dr. Kendra and her coauthors for conducting a study in such a rare tumor. “I think we can say desmoplastic melanoma ...
