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Skin Cancer
Immunotherapy

Expert Point of View: Stefania Scala, MD

Formal discussant Stefania Scala, MD, of the Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, was impressed by the findings of KEYNOTE-629. “The second interim analysis for the locally advanced disease cohort and updated data for the recurrent/metastatic disease cohort of KEYNOTE-629 had ...

Skin Cancer
Immunotherapy

Single-Agent Pembrolizumab Yields High Response Rates in Patients With Cutaneous Squamous Cell Carcinoma

Single-agent pembrolizumab achieved durable responses and promising survival in patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma, according to the second interim analysis of the phase II ­KEYNOTE-629 study, which was presented at the virtual American...

Lymphoma
Immunotherapy

Loncastuximab Tesirine-lpyl for Heavily Pretreated Patients With Relapsed or Refractory DLBCL: LOTIS-2

As reported in The Lancet Oncology by Caimi et al, the phase II LOTIS-2 trial has shown that the CD19-directed antibody–alkylating drug conjugate loncastuximab tesirine-lpyl produced durable responses in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study supported ...

Breast Cancer
Immunotherapy

Pertuzumab/High-Dose Trastuzumab in Patients With HER2-Positive Metastatic Breast Cancer and Progressive Brain Metastases

In the phase II PATRICIA trial reported in the Journal of Clinical Oncology, Nancy U. Lin, MD, and colleagues found that pertuzumab plus high-dose trastuzumab produced central nervous system (CNS) objective responses and clinical benefit in 68% of patients with HER2-positive metastatic breast...

Colorectal Cancer
Immunotherapy

Trastuzumab Deruxtecan-nxki in HER2-Positive Metastatic Colorectal Cancer: DESTINY-CRC01

In the phase II DESTINY-CRC01 trial reported in The Lancet Oncology, Salvatore Siena, MD, and colleagues found that trastuzumab deruxtecan-nxki produced durable responses in patients with previously treated HER2-positive metastatic colorectal cancer. Study Details In the trial, 78 patients from...

Breast Cancer
Immunotherapy

Cardiac Safety, Efficacy of Neoadjuvant Pertuzumab/Trastuzumab for Early-Stage HER2-Positive Breast Cancer

Long-term cardiac safety and efficacy have been confirmed for the combination of pertuzumab plus trastuzumab in patients with early-stage HER2-positive breast cancer, according to the final analysis of the phase II BERENICE trial reported by Chau T. Dang, MD, and colleagues at the ESMO Breast...

Immunotherapy
Skin Cancer

Pembrolizumab/Ipilimumab After Disease Progression on PD-1/PD-L1 Inhibitor Therapy in Advanced Melanoma

In a phase II trial reported in the Journal of Clinical Oncology, Olson et al found that pembrolizumab plus low-dose ipilimumab produced durable responses in patients with advanced melanoma whose disease had progressed on immediate prior PD-1 or PD-L1 inhibitor therapy. Study Details In the U.S....

Lung Cancer
Immunotherapy

Stage IV PD-L1–High Non–Small Cell Lung Cancer: Immunotherapy Alone or With Chemotherapy?

Except in patients with no smoking history, the addition of chemotherapy to immunotherapy does not add benefit as a first-line treatment in patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) and high expression of PD-L1, according to real-world experience. Outcomes from the U.S. ...

Breast Cancer
Immunotherapy
Symptom Management

Incidence of Interstitial Lung Disease Related to Trastuzumab Deruxtecan-nxki in Patients With HER2-Positive Metastatic Breast Cancer

Drug-related interstitial lung disease occurred in less than 16% of patients with HER2-positive metastatic breast cancer following treatment with trastuzumab deruxtecan-nxki (T-DXd) at the approved dose of 5.4 mg/kg. In addition, the majority of these cases were classified as grade 1 or 2,...

Breast Cancer
Immunotherapy

Atezolizumab/Carboplatin as Immune Induction in Patients With Metastatic Invasive Lobular Breast Cancer

First results from the phase II GELATO study evaluating atezolizumab plus carboplatin presented at the ESMO Breast Cancer Virtual Congress 2021 demonstrated clinical benefit in patients with metastatic invasive lobular breast cancer, particularly in patients with triple-negative invasive lobular...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Thomas Herzog, MD

Discussant of this phase II study, Thomas Herzog, MD, Deputy Director of the University of Cincinnati Cancer Center and Professor of Obstetrics and Gynecology at the UC College of Medicine, called the results “very exciting.” “The 33% response rate with the combination of ixabepilone plus...

Gynecologic Cancers
Immunotherapy

Study Finds Ixabepilone Plus Bevacizumab Active in Platinum-Resistant or Recurrent Ovarian Cancer

The addition of bevacizumab to ixabepilone could be a promising treatment strategy for a group of patients with cancer currently lacking therapeutic options, according to data presented during the virtual edition of the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer.1...

Breast Cancer
Immunotherapy

Long-Term Analysis of Short-HER Trial Reported: Shorter Duration of Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer

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 disease recurrence. High-risk patients, however, derived considerably ...

Kidney Cancer
Gynecologic Cancers
Hepatobiliary Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Kidney and Endometrial Cancers, Cholangiocarcinoma

Recently, the U.S. Food and Drug Administration (FDA) has granted Priority Review to the combination of pembrolizumab and lenvatinib for the treatment of both advanced renal cell carcinoma (RCC) and endometrial carcinoma. The FDA also granted Priority Review to ivosidenib for the treatment of...

Breast Cancer
Immunotherapy

Margetuximab-cmkb: A Novel Agent Overshadowed by an Abundance of Options in HER2-Positive Breast Cancer

It is incredible to reflect upon the scientific advances in the treatment of HER2-positive breast cancer over the past 23 years. Once considered the worst subtype of breast cancer, HER2-positive disease is now associated with the best long-term outcomes in this age of targeted treatments. With a...

Breast Cancer
Immunotherapy

Margetuximab-cmkb Plus Chemotherapy Prolongs Progression-Free Survival in Heavily Pretreated HER2-Positive Breast Cancer

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...

Skin Cancer
Immunotherapy

Study Finds Adjuvant Immunotherapy of Benefit to Patients With Stage IIB/C Melanoma

A significant survival advantage accrued to patients with stage IIB and IIC cutaneous melanoma who received adjuvant immunotherapy, a large retrospective cohort study reported at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 The 3-year overall...

Lung Cancer
Immunotherapy

Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression

On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor...

Skin Cancer
Immunotherapy

Expert Point of View: Alexander Eggermont, MD, PhD

Formal discussant of CheckMate 915, Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands, suggested that the lower doses of ipilimumab used in the current study may explain the lack of effect on relapse-free survival. The...

Skin Cancer
Immunotherapy

Comparing Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage III to IV Melanoma

The addition of ipilimumab to nivolumab failed to improve outcomes compared with nivolumab alone as adjuvant therapy for resected melanoma, according to the results of the CheckMate 915 trial, presented at the virtual edition of the American Association for Cancer Research (AACR) Annual Meeting...

Immunotherapy
Hematologic Malignancies

Bispecific Antibody Platform: Early Data in Relapsed and Refractory Myeloma

“There was never a night or a problem that could defeat sunrise or hope.” —Bernard Williams To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting...

Lung Cancer
Immunotherapy

Expert Point of View: Jhanelle E. Gray, MD

Formal discussant of the CheckMate 816 trial, Jhanelle E. Gray, MD, of Moffitt Cancer Center, Tampa, said that both neoadjuvant and adjuvant therapies have been shown to improve overall survival and relapse-free survival in non–small cell lung cancer (NSCLC). “Overall, neoadjuvant outcomes compare...

Lung Cancer
Immunotherapy

CheckMate 816: Neoadjuvant Nivolumab Plus Chemotherapy Boosts Pathologic Complete Response in Resectable NSCLC

Neoadjuvant chemotherapy with nivolumab plus platinum-doublet chemotherapy significantly improved pathologic complete response rates compared with chemotherapy alone in patients with resectable stage IB to IIIA non–small cell lung cancer (NSCLC), according to the results of the CheckMate 816 study...

Gynecologic Cancers
Immunotherapy

IMagyn050 Trial: Addition of Atezolizumab to Bevacizumab and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer

As reported in the Journal of Clinical Oncology by Kathleen N. Moore, MD, and colleagues, the phase III IMagyn050/GOG 3015/ENGOT-OV39 trial has shown that the addition of atezolizumab to bevacizumab and chemotherapy did not significantly improve progression-free survival in patients with newly...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer

On May 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...

Bladder Cancer
Lung Cancer
Immunotherapy

FDA Pipeline: Priority Reviews of Treatments for Bladder and Lung Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....

Lymphoma
Immunotherapy

Brentuximab Vedotin Plus Chemotherapy in Newly Diagnosed Early-Stage Unfavorable-Risk Hodgkin Lymphoma

In a pilot study reported in the Journal of Clinical Oncology, Kumar et al found that the combination of brentuximab vedotin with AVD (doxorubicin, vinblastine, and dacarbazine) was highly active in patients with newly diagnosed, early-stage, unfavorable-risk Hodgkin lymphoma and may permit the...

Hematologic Malignancies
Immunotherapy
Symptom Management

Antiviral T Cells for BK Virus–Associated Hemorrhagic Cystitis

A phase II trial has found found that BK virus (BKV)-specific T cells from healthy donors were safe and effective as an off-the-shelf therapy for BKV-associated hemorrhagic cystitis, a painful complication that is common after allogeneic stem cell transplants for patients with leukemia or lymphoma. ...

Immunotherapy
Lung Cancer
Genomics/Genetics

First-Line Immune Checkpoint Inhibitor Monotherapy vs Chemoimmunotherapy in Advanced NSCLC According to KRAS Variant Status

In a study reported in a research letter in JAMA Oncology, Sun et al found that first-line immune checkpoint inhibitor monotherapy was associated with better overall survival among patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% and KRAS variant vs KRAS...

Gastrointestinal Cancer
Gastroesophageal Cancer
Hepatobiliary Cancer
Immunotherapy

More From the FDA ODAC: Votes on Agents for Pretreated Hepatocellular Carcinoma and Gastric Cancer

More news has emerged from this week’s meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). The group voted 8 to 0 in favor of continuing the accelerated approval for pembrolizumab in sorafenib-pretreated patients with hepatocellular carcinoma; 6 to 2...

Lung Cancer
Immunotherapy

Five-Year Efficacy Outcomes With Pembrolizumab vs Chemotherapy in Metastatic NSCLC With PD-L1 Tumor Proportion Score of at Least 50%

As reported by Martin Reck, MD, PhD, and colleagues in the Journal of Clinical Oncology, the 5-year follow-up of the pivotal phase III KEYNOTE-024 trial shows maintained overall survival benefit in patients treated with pembrolizumab vs chemotherapy—despite substantial crossover to the...

Breast Cancer
Immunotherapy

Adjuvant Trastuzumab With or Without Chemotherapy in Older Patients With HER2-Positive Breast Cancer: Health-Related Quality of Life

In an analysis from the Japanese RESPECT trial reported in the Journal of Clinical Oncology, Taira et al found that adjuvant trastuzumab monotherapy was associated with better health-related quality of life (QoL) vs trastuzumab plus standard chemotherapy for at least 12 months in women aged 70 to...

Bladder Cancer
Immunotherapy

FDA ODAC Votes in Favor of Retaining Accelerated Approval for Bladder Cancer Treatments

Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...

hematologic malignancies
immunotherapy

Andrew D. Zelenetz, MD, PhD, and Stephen J. Schuster, MD, on CAR T Cells for Hematologic Malignancies: Where We’re At

Breast Cancer
Immunotherapy

Sacituzumab Govitecan-hziy Improves Survival vs Single-Agent Chemotherapy in Metastatic Triple-Negative Breast Cancer

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...

Skin Cancer
Immunotherapy

Health-Related Quality of Life With Adjuvant Pembrolizumab vs Placebo in Resected Stage III Melanoma

As reported in The Lancet Oncology by Andrew Bottomley, PhD, and colleagues, an analysis of the phase III EORTC 1325-MG/KEYNOTE-054 trial showed no clinically significant decline in health-related quality of life (HRQoL) with adjuvant pembrolizumab vs placebo in resected high-risk stage III...

Breast Cancer
Immunotherapy

FDA ODAC Votes in Favor of Maintaining Accelerated Approval of Atezolizumab/Nab-paclitaxel for PD-L1–Positive, Metastatic Triple-Negative Breast Cancer

Roche announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted seven to two in favor of maintaining accelerated approval of atezolizumab in combination with chemotherapy (nanoparticle albumin-bound paclitaxel, or nab-paclitaxel) for the treatment of ...

Lymphoma
Immunotherapy

FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for Large B-Cell Lymphoma

On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, ...

Multiple Myeloma
Immunotherapy

Anti-BCMA–Directed CAR T-Cell Gene Therapy in Relapsed or Refractory Myeloma

"The noblest pleasure is the joy of understanding.” —Leonardo da Vinci To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel...

Skin Cancer
Immunotherapy

Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma

On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for...

Issues in Oncology
Immunotherapy

‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies to Be Discussed at FDA Oncologic Drugs Advisory Committee Meeting

In a Perspective article 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 (OCD), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie,...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Bemarituzumab Granted Breakthrough Therapy Designation for FGFR2b-Overexpressing, HER2-Negative Gastric Cancer

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b)-overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma...

Lymphoma
Immunotherapy

Glofitamab for Relapsed or Refractory B-Cell Lymphoma

In a phase I trial reported in the Journal of Clinical Oncology, Hutchings et al found that the bivalent CD20-targeting T-cell–engaging bispecific antibody glofitamab produced high response rates and was associated with manageable toxicity in patients with predominantly refractory aggressive B-cell ...

Gynecologic Cancers
Immunotherapy

FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Endometrial Cancer

On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior...

Skin Cancer
Immunotherapy

Improvement in Survival With Adjuvant Pembrolizumab for Resected Stage III Melanoma

As reported in The Lancet Oncology by Alexander M.M. Eggermont, MD, and colleagues, the pivotal phase III EORTC 1325/KEYNOTE-054 trial has shown significant improvement in the secondary endpoint of distant metastasis–free survival—as well as continued benefit in the primary endpoint of...

Gynecologic Cancers
Immunotherapy

Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

In a phase II study (innovaTV 204/GOG-3023/ENGOT-cx6) reported in The Lancet Oncology, Robert L. Coleman, MD, and colleagues found that the tissue factor–directed antibody-drug conjugate tisotumab vedotin produced durable responses in previously treated patients with recurrent or metastatic...

Breast Cancer
Immunotherapy

Pembrolizumab Monotherapy for Heavily Pretreated Patients With Metastatic Breast Cancer and High Tumor Mutational Burden

Findings from the ASCO-designed phase II Targeted Agent and Profiling Utilization Registry (TAPUR) basket trial, reported in the Journal of Clinical Oncology by Alva et al, indicated that pembrolizumab showed activity in heavily pretreated patients with metastatic breast cancer and high mutational...

Kidney Cancer
Bladder Cancer
Prostate Cancer
Immunotherapy

Genitourinary Oncology Highlights 2020–2021 Almanac

Landmark changes in the treatment of genitourinary cancers have occurred over the past year, as summarized in this year’s Genitourinary Oncology Almanac from The ASCO Post. Starting with our area of focus, metastatic renal cell carcinoma, the saga continues with two more positive phase III trials...

Immunotherapy

Immune Checkpoint Inhibitors and Cutaneous Toxicity: Population-Level Analysis

Immune checkpoint inhibitors have transformed treatment for many advanced cancers, but short-term clinical trials and small observational studies have linked the medications with various side effects, most commonly involving the skin. A more comprehensive, population-level analysis now provides a...

Bladder Cancer
Gynecologic Cancers
Hepatobiliary Cancer
Solid Tumors
Colorectal Cancer
Immunotherapy

FDA Pipeline: Recent Designations in Urothelial Cancer, Cervical Cancer, Cholangiocarcinoma, and More

Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...

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