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Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab Shows Efficacy in High-Risk Stage II Melanoma in Adults and Children Older Than 12

Adjuvant pembrolizumab reduced the risk of recurrence in adults and children older than age 12 with high-risk stage II (AJCC 8th edition, stage IIB/IIC) melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial, presented during the European Society for...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Mansoor Raza Mirza, MD

“The standard of care [in advanced cervical cancer] has been the addition of bevacizumab to platinum-based chemotherapy since 2014. Even with the addition of bevacizumab, we still need to do better. There is a substantial unmet need for new therapies,” said invited discussant Mansoor Raza Mirza,...

Gynecologic Cancers
Immunotherapy

Study Shows Pembrolizumab Plus Chemotherapy Improves Survival in Advanced Cervical Cancer

The addition of pembrolizumab to chemotherapy prolonged survival in recurrent, persistent, or metastatic cervical cancer, according to the results of the first interim analysis of the ­KEYNOTE-826 trial, presented at a Presidential Symposium during the European Society for Medical Oncology (ESMO)...

Lung Cancer
Immunotherapy

Expert Point of View: Ichiro Yoshino, MD, PhD

Ichiro Yoshino, MD, PhD, Professor and Chairman of the Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, Japan, reviewed the finer details of the IMpower010 exploratory analysis.1 He maintained that atezolizumab’s benefit does, indeed, seem to favor some patient...

Lung Cancer
Immunotherapy

IMpower010: Benefits Observed With Atezolizumab Regardless of Stage, Type of Prior Treatment

In an exploratory analysis of the pivotal phase III IMpower010 trial in stage II–IIIA non–small cell lung cancer (NSCLC), continued treatment with the monoclonal antibody atezolizumab after surgery and chemotherapy improved disease-free survival regardless of the type of surgery or chemotherapy...

Breast Cancer
Immunotherapy

Expert Point of View: Shanu Modi, MD

Shanu Modi, MD, of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, New York, called the DESTINY-Breast03 results,1 which showed a highly significant benefit for fam-trastuzumab deruxtecan-nxki (T-DXd) over trastuzumab emtansine (T-DM1), “unprecedented.” She suggested they...

Breast Cancer
Immunotherapy

DESTINY Breast03 Trial Supports Second-Line Use of T-DXd in Metastatic HER2-Positive Breast Cancer

The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) may become a new option as a second-line treatment of patients with HER2-positive unresectable or metastatic breast cancer, based on results from the global phase III DESTINY-Breast03 trial. These findings were presented by Javier...

Skin Cancer
Gynecologic Cancers
Prostate Cancer
Breast Cancer
Solid Tumors
Hepatobiliary Cancer
Gastroesophageal Cancer
Immunotherapy

FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space

Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...

Lung Cancer
Immunotherapy

Jyoti Patel, MD, Offers Thoughts on Maintenance Durvalumab Utilization

Study discussant Jyoti Patel, MD, Medical Director of Thoracic Oncology and Assistant Director for Clinical Research at the Lurie Cancer Center of Northwestern University, Chicago, called the research “important for many reasons.” Although the study analyzed data from both open and closed claims,...

Lung Cancer
Immunotherapy

Maintenance Durvalumab: Increased Utilization May Improve Outcomes in NSCLC

Maintenance durvalumab, the standard-of-care treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC), remains significantly underutilized, according to data presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung...

Lymphoma
Immunotherapy

Tackling a Growing Need: Options After CAR T-Cell Therapy for Lymphoma

For aggressive B-cell lymphomas, chimeric antigen receptor (CAR) T-cell therapy saves lives, but relapse remains common, and a second-line standard of care is lacking. During the 2021 Pan Pacific Lymphoma Conference, Grzegorz (Greg) S. Nowakowski, MD, Professor of Medicine and Oncology, Lymphoma...

Lung Cancer
Immunotherapy

Black Patients With Advanced NSCLC Receiving Immunotherapy May Have a Lower Risk of Death Than White Patients

Collectively, Black Americans have the highest death rate and shortest survival of any racial/ethnic group in the United States for most cancers; Black men also have the highest cancer incidence rate. Despite improvements in survival disparities between Black and White Americans in specific cancers ...

Kidney Cancer
Immunotherapy

Rates of Postprotocol Immunotherapy Use in Patients Enrolled in Kidney Cancer Clinical Trials

In an analysis reported in JAMA Network Open, Sharp et al identified the frequency of use of postprotocol PD-1/PD-L1 inhibitors in control group patients receiving the tyrosine kinase inhibitor sunitinib in randomized trials comparing PD-1/PD-L1 inhibitor–containing combination therapy vs sunitinib ...

Lung Cancer
Immunotherapy

Adjuvant Atezolizumab Following Adjuvant Chemotherapy for Resected Stage IB to IIIA NSCLC

In the phase III IMpower010 trial reported in The Lancet, Enriqueta Felip, MD, and colleagues found that the use of adjuvant atezolizumab after adjuvant platinum-based chemotherapy significantly improved disease-free survival vs best supportive care in patients with resected stage II to IIIA...

Hematologic Malignancies
Leukemia
Immunotherapy
Global Cancer Care

A Look at Tomorrow’s CAR T-Cell Therapy Today

Some of the most impressive data on chimeric antigen receptor (CAR) T-cell therapy have come from studies conducted in China. Attendees at the 2021 Pan Pacific Lymphoma Conference heard from one of the leading Chinese investigators, Peihua (Peggy) Lu, MD, of Lu Daopei Hospital, who described the...

Lymphoma
Immunotherapy

Axicabtagene Ciloleucel for Adult Patients With Primary Mediastinal B-Cell Lymphoma: Real-World Outcomes

In a retrospective cohort study reported in a research letter in Blood Advances, Jennifer L. Crombie, MD, and colleagues found that axicabtagene ciloleucel produced high overall and complete response rates in patients with primary mediastinal B-cell lymphoma. They also observed some evidence to...

Leukemia
Immunotherapy

FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL

On October 1, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ZUMA-3 Efficacy was evaluated ...

Immunotherapy

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...

lung cancer
immunotherapy

Nasser K. Altorki, MD, on NSCLC: Adjuvant Atezolizumab for Stage IB–IIIA Disease

Nasser K. Altorki, MD, of Weill Medical College of Cornell University and NewYork-Presbyterian Hospital, discusses phase III data from the IMpower010 study, which showed that, compared with best supportive care, atezolizumab improved disease-free survival in patients with stage II–IIIA non–small cell lung cancer. These findings applied across most disease stages and most surgery types and chemotherapy regimens, as well as in patients with nodal involvement (Abstract PL02.05).

Multiple Myeloma
Immunotherapy

CASSIOPEIA Part 2: Maintenance Daratumumab After Initial Therapy for Newly Diagnosed Multiple Myeloma

As reported in The Lancet Oncology by Philippe Moreau, MD, and colleagues, an interim analysis of part 2 of the phase III CASSIOPEIA trial has shown significantly prolonged progression-free survival with maintenance daratumumab vs observation following induction and consolidation with or without...

Gynecologic Cancers
Immunotherapy

Pembrolizumab and Lenvatinib in Advanced Endometrial Carcinoma

On July 21, 2021, pembrolizumab in combination with lenvatinib was granted regular approval for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient who have disease progression following prior systemic therapy in any...

Bladder Cancer
Immunotherapy

Nivolumab for Adjuvant Treatment of Urothelial Carcinoma

On August 19, 2021, the PD-1 inhibitor nivolumab was approved for adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.1 This is the first approval by the U.S. Food and Drug Administration for adjuvant treatment of patients...

Kidney Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab for First-Line Treatment of Advanced Renal Cell Carcinoma

On August 10, 2021, the combination of lenvatinib plus pembrolizumab was approved for first-line treatment of adults with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings from the three-arm, open-label, phase III CLEAR trial (Study 307/KEYNOTE-581;...

multiple myeloma
immunotherapy

Saad Z. Usmani, MBA, MD, on Multiple Myeloma: Updated Results From the CARTITUDE-1 Study of Ciltacabtagene Autoleucel

Saad Z. Usmani, MBA, MD, of the Levine Cancer Institute, discusses new data on the CAR T-cell therapy ciltacabtagene autoleucel, a single infusion of which yielded early, deep, and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma (Oral Abstract MM-119).

Immunotherapy
Solid Tumors

Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Solid Tumors

On August 17, 2021, dostarlimab-gxly, aPD-1 blocking monoclonal antibody, was granted accelerated approval for adults with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have had disease progression...

Immunotherapy
Lymphoma

Lymphoid Malignancies: What’s Next for Antibody-Drug Conjugates?

Antibody-drug conjugates are improving outcomes of patients with lymphoma, often those who have exhausted treatment options after chimeric antigen receptor (CAR) T-cell therapy. Four available antibody-drug conjugates are in the clinic, with brentuximab vedotin moving into the front-line...

Lymphoma
Immunotherapy

Long-Term Outcomes in JULIET Trial of Tisagenlecleucel for Relapsed or Refractory Aggressive B-Cell Lymphomas

As reported by Stephen J. Schuster, MD, and colleagues in The Lancet Oncology, long-term outcomes of the pivotal phase II JULIET trial showed overall and complete response rates of 53% and 39% in adult patients with relapsed or refractory aggressive B-cell lymphomas treated with the T-cell...

kidney cancer
immunotherapy

Naveen S. Vasudev, PhD, MBChB, on RCC: Changing the Dosing Schedule of Ipilimumab Plus Nivolumab

Naveen S. Vasudev, PhD, MBChB, of the University of Leeds, discusses phase II results from the PRISM trial, which showed that giving ipilimumab every 12 weeks instead of every 3 weeks, in combination with nivolumab, led to lower rates of grade 3 and 4 toxicities in patients with advanced renal cell carcinoma. Efficacy appeared to be comparable between both arms (Abstract LBA29).

Lung Cancer
Immunotherapy

DESTINY-Lung01: Fam-trastuzumab Deruxtecan-nxki in Previously Treated HER2-Mutant NSCLC

In the phase II DESTINY-Lung01 trial, presented at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract LBA45) and concurrently reported in The New England Journal of Medicine, Bob T. Li, MD, PhD, MPH, and colleagues found that fam-trastuzumab deruxtecan-nxki produced durable...

Kidney Cancer
Immunotherapy

COSMIC-021: Cabozantinib Plus Atezolizumab for Advanced Renal Cell Carcinoma

In the phase Ib COSMIC-021 trial reported in the Journal of Clinical Oncology, Sumanta K. Pal, MD, FASCO, and colleagues found that the combination of cabozantinib and atezolizumab produced durable responses in patients with advanced renal cell carcinoma (RCC). Study Details One hundred and two...

Lung Cancer
Immunotherapy

Addition of Ramucirumab to Gemcitabine in Second-Line Treatment of Malignant Pleural Mesothelioma

In the Italian phase II RAMES trial reported in The Lancet Oncology, Pinto et al found that the addition of ramucirumab to gemcitabine improved overall survival in the second-line treatment of malignant pleural mesothelioma. As noted by the investigators, “There is a preclinical rationale for...

Gynecologic Cancers
Immunotherapy

FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...

kidney cancer
immunotherapy

Toni K. Choueiri, MD, on Renal Cell Carcinoma: Quality-of-Life Data From KEYNOTE-564 on Pembrolizumab vs Placebo

Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses patient-reported outcomes for quality of life in the KEYNOTE-564 study, which previously met its primary endpoint of disease-free survival with adjuvant pembrolizumab vs placebo following surgery for renal cell carcinoma (Abstract 653O).

Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab for High-Risk Stage II Melanoma: Efficacy and Safety Examined

Adjuvant pembrolizumab reduced the risk of disease recurrence in adults and children aged 12 years and older with high-risk stage II melanoma vs placebo, according to a late-breaking interim analysis of the phase III KEYNOTE-716 trial presented by Jason J. Luke, MD, and colleagues at the European...

Lymphoma
Immunotherapy

Bispecific Antibody Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

In a phase I/II study reported in The Lancet, Hutchings et al found that the novel bispecific antibody epcoritamab produced high response rates in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Epcoritamab works by targeting CD3 and CD20 and inducing T-cell–mediated cytotoxic...

skin cancer
immunotherapy

Jason J. Luke, MD, on Melanoma: KEYNOTE-716 Trial of Pembrolizumab vs Placebo

Jason J. Luke, MD, of UPMC Hillman Cancer Center, discusses phase III results showing that adjuvant pembrolizumab for patients with resected stage IIB and IIC melanoma decreased the risk of disease recurrence or death by 35% compared with placebo. It was also associated with significantly prolonged recurrence-free survival (Abstract LBA3).

breast cancer
immunotherapy

Javier Cortés, MD, PhD, on HER2-Positive Breast Cancer: Trastuzumab Deruxtecan vs Trastuzumab Emtansine

Javier Cortés, MD, PhD, of Barcelona’s IOB Institute of Oncology, discusses phase III data from the DESTINY-Breast03 study, which support trastuzumab deruxtecan becoming the standard of care for second-line treatment of women with HER2-positive metastatic breast cancer (Abstract LBA1).

gynecologic cancers
immunotherapy

Nicoletta Colombo, MD, on Cervical Cancer: KEYNOTE-826 Trial of Pembrolizumab Plus Chemotherapy

Nicoletta Colombo, MD, of the Istituto Europeo Oncologico, discusses phase III results that showed improvements in progression-free and overall survival with a combination of pembrolizumab plus chemotherapy, compared with placebo and chemotherapy, for patients with persistent, recurrent, or metastatic cervical cancer. These benefits were seen regardless of PD-L1 expression and concomitant bevacizumab use, suggesting that pembrolizumab plus chemotherapy, with or without bevacizumab, may be a new standard of care for this population (Abstract LBA2).

Breast Cancer
Immunotherapy

DESTINY Breast03: Second-Line Fam-Trastuzumab Deruxtecan-nxki for Metastatic HER2-Positive Breast Cancer

Fam-trastuzumab deruxtecan-nxki (T-DXd) showed statistically significant improvement in progression-free survival vs trastuzumab emtansine (T-DM1) in second-line treatment for HER2-positive unresectable or metastatic breast cancer, according to results from the global phase III DESTINY-Breast03...

Gynecologic Cancers
Immunotherapy

KEYNOTE-826: Pembrolizumab Plus Chemotherapy in Advanced Cervical Cancer

The addition of pembrolizumab to chemotherapy prolonged survival in recurrent, persistent, or metastatic cervical cancer, according to results of the KEYNOTE-826 study presented at the European Society for Medical Oncology (ESMO) Congress 2021 by Nicoletta Colombo, MD, and colleagues (Abstract...

Gastrointestinal Cancer
Immunotherapy
Gastroesophageal Cancer

DESTINY-Gastric02: Fam-Trastuzumab Deruxtecan-nxki Produces Responses in Patients With HER2-Positive Gastric Cancers

In the primary analysis of the phase II DESTINY-Gastric02 trial, fam-trastuzumab deruxtecan-nxki (T-DXd) produced clinically meaningful and durable responses in Western patients with advanced HER2-positive gastric or gastroesophageal junction cancers whose disease had progressed after a...

breast cancer
immunotherapy

Helena M. Earl, MBBS, PhD, on HER2-Positive Early Breast Cancer: A Meta-analysis of Trastuzumab Trials

Helena M. Earl, MBBS, PhD, of the University of Cambridge, discusses an individual patient data meta-analysis of noninferiority randomized clinical trials to determine whether a duration of less than the standard of 12 months of adjuvant trastuzumab is noninferior for treatment outcomes in patients with HER2-positive early breast cancer (Abstract LBA11).

Immunotherapy

Can Diabetes Affect the Efficacy of Immune Checkpoint Inhibitors in Patients With Advanced Cancer?

Investigators from 22 institutions aimed to evaluate the impact of diabetes mellitus in a retrospective cohort of patients with advanced cancer treated with a single-agent immune checkpoint inhibitor. In a report presented by Cortellini et al at the European Society for Medical Oncology (ESMO)...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Carol Aghajanian, MD

“The phase III ENGOT/GCIG study1 proved to be negative, with no advantage seen with the extension of bevacizumab treatment,” said the abstract’s invited discussant, Carol Aghajanian, MD, Chief of the Medical Gynecologic Oncology Service at Memorial Sloan Kettering Cancer Center, New York. Dr....

Gynecologic Cancers
Immunotherapy

Bevacizumab in Advanced Ovarian Cancer: Phase III Trial Finds More Is Not Better

In advanced ovarian cancer, the duration of maintenance bevacizumab should remain 15 months, according to the European multicenter phase III ENGOT/GCIG trial. These results were presented during the 2021 ASCO Annual Meeting by Jacobus Pfisterer, MD, PhD, of the AGO Study Group and Gynecologic...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Ana Oaknin, MD, PhD

The innovaTV 204 trial’s invited discussant, Ana Oaknin, MD, PhD, Head of the Gynecologic Cancer Program at Vall d’Hebron Institute of Oncology in Barcelona, was encouraged by the study’s findings. “Of note, the response rate was 24%, the time to response was short, and the median duration of...

Gynecologic Cancers
Immunotherapy

Novel Treatments Show Activity in Advanced Cervical Cancer

The treatment of recurrent or metastatic cervical cancer has not changed much in recent years, but according to preliminary trials presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, checkpoint inhibitors and antibody-drug conjugates may become new options. In the...

Gynecologic Cancers
Immunotherapy

Expert Point of View: Mansoor Raza Mirza, MD

The invited discussant of EMPOWER-Cervical 1 was Mansoor Raza Mirza, MD, Chief Oncologist at Copenhagen University Hospital and Chairman of the European Network of Gynaecological Oncology Trials group (ENGOT). Dr. Mirza called the findings “amazing” and predicted they will “usher in a new era” in...

Gynecologic Cancers
Immunotherapy

Immunotherapy With Cemiplimab-rwlc Yields Survival Benefit in Advanced Cervical Cancer

The PD-L1 inhibitor cemiplimab-rwlc has become the first immunotherapy to yield a statistically significant and clinically meaningful survival benefit in recurrent or metastatic cervical cancer progressing after first-line platinum-containing chemotherapy. Patients were enrolled irrespective of...

Gynecologic Cancers
Immunotherapy

Gynecologic Cancers 2020–2021 Almanac

The past year has been a remarkable and noteworthy time with much exciting progress made in gynecologic cancers, despite the underlying presence of the COVID-19 pandemic. Several key studies were presented in 2020–2021 that detailed the results of novel therapies for our patients with cervical,...

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