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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...

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...

solid tumors

Long-Term Therapy With Bintrafusp Alfa in HPV-Associated Cancers

Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor fused to a human IgG1 monoclonal antibody blocking PD-L1, showed long-term efficacy and a manageable safety profile in patients with pretreated, immune checkpoint...

solid tumors
genomics/genetics

ATR Inhibitor Ceralasertib in ARID1A-Deficient and ARID1A-Intact Solid Tumors

In an ongoing phase II study, Aggarwal et al evaluated the efficacy of the ATR inhibitor ceralasertib alone and in combination with olaparib in patients with ARID1A-deficient and ARID1A-intact solid tumors. They observed antitumor activity with ceralasertib monotherapy in ARID1A-deficient solid...

breast cancer

Phase III Trial Investigates Extended Adjuvant Endocrine Therapy for Postmenopausal Patients With Breast Cancer

For patients with early-stage hormone receptor–positive breast cancer, extending the duration of letrozole after tamoxifen—for up to 8 years of total endocrine therapy—significantly improved invasive disease–free survival and overall survival over the standard treatment of approximately 5 years of...

thyroid cancer

FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer

On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth...

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

Study Shows Sentinel Lymph Node Biopsy to Be ‘Viable Option’ for Surgical Staging of Endometrial Cancer

Sentinel lymph node biopsy “had similar diagnostic accuracy and prognostic ability as lymphadenectomy in patients with high-grade endometrial cancer at greatest risk for nodal metastases,” according to the SENTOR trial, a prospective cohort study of 156 patients with clinical stage I disease. Using ...

gynecologic cancers

Lenvatinib/Pembrolizumab Improves Survival in Advanced Endometrial Cancer in a Phase III Trial

In the first report from the pivotal phase III KEYNOTE-775/Study 309 trial, the combination of lenvatinib, a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3 kinases, and the PD-1 inhibitor pembrolizumab significantly improved multiple outcomes compared with standard single-agent chemotherapy in ...

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

Hormonal Intrauterine Device Under Study for Managing Early Endometrial Cancer

Disease regression was observed in 82% of women with endometrial hyperplasia with atypia and 43% of women with endometrial cancer after treatment for 6 months with a hormonal intrauterine device, in a phase II study reported during the virtual edition of the Society of Gynecologic Oncology (SGO)...

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

Recent FDA Approvals in Endometrial Cancer

In recent months, the U.S. Food and Drug Administration approved two treatment options for patients with endometrial cancer, which are summarized herein. Dostarlimab-gxly for dMMR Endometrial Cancer On April 22, 2021, the FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for adult...

gynecologic cancers

Benefit of Niraparib Maintenance Therapy Extends Beyond First Disease Progression in Recurrent Ovarian Cancer

The PARP (poly [adp-ribose] polymerase) inhibitor niraparib is safe for long-term use and effective as maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer, according to data presented by Ursula A. Matulonis, MD, at the Society of Gynecologic Oncology (SGO) 2021...

gynecologic cancers

Niraparib Plus Bevacizumab Shows Clinical Benefit in Advanced Ovarian Cancer

The addition of niraparib maintenance to first-line platinum-based chemotherapy with bevacizumab demonstrated clinical benefit in patients with advanced ovarian cancer, according to data from the OVARIO study presented by Melissa M. Hardesty, MD, MPH, during the Society of Gynecologic Oncology...

Expert Point of View: Deborah Armstrong, MD

The invited discussant of the SOLO-1 trial, Deborah Armstrong, MD, Professor of Oncology and Director of the Breast and Ovarian Surveillance Service at Johns Hopkins Medicine, said the update provides “important information for us.” It shows that 2 years of maintenance olaparib conveys “a really...

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

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,1 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...

gynecologic cancers

Overall Survival With Olaparib vs Placebo Maintenance in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and BRCA1/2 Mutation

As reported in The Lancet Oncology by Andrés Poveda, MD, and colleagues, the phase III SOLO2/ENGOT-Ov21 trial has shown a large numeric but statistically nonsignificant improvement in the secondary endpoint of overall survival with olaparib tablet maintenance therapy vs placebo in patients with...

Expert Point of View: Thomas Herzog, MD

The discussant of the fuzuloparib abstract at the Society of Gynecologic Oncology meeting was Thomas Herzog, MD, Deputy Director of the University of Cincinnati (UC) Cancer Center and Professor of Obstetrics and Gynecology at the UC College of Medicine. He said that these data have already led to...

gynecologic cancers

Fuzuloparib Maintenance Therapy Improves Progression-Free Survival in Patients With Recurrent Ovarian Cancer

A new poly (ADP-ribose) polymerase (PARP) inhibitor could soon be joining an already crowded treatment landscape in ovarian cancer, according to data presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer, which was held virtually.1 Results of the phase III...

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

Expert Point of View: Kunle Odunsi, MD, PhD, and Lilian T. Gien, MD, MSc

Comments on the OUTBACK trial were provided by invited discussant Kunle Odunsi, MD, PhD, Professor of Obstetrics and Gynecology, Dean for Oncology, and Director of the University of Chicago Medicine Comprehensive Cancer Center. Lilian T. Gien, MD, MSc, Associate Professor of Oncology at the...

gynecologic cancers

OUTBACK: No Benefit for Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

In women with locally advanced cervical cancer, adjuvant chemotherapy adds no benefit to standard cisplatin-based chemoradiation, results of the international phase III OUTBACK study have shown,1 as reported at the 2021 ASCO Annual Meeting by Linda R. Mileshkin, MD, Professor of Medical Oncology at ...

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,...

lung cancer

Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With KRAS Inhibitor in Lung Cancer

The KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses extended to all...

lung cancer
immunotherapy

Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC

Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...

breast cancer

Extended Follow-up of PALOMA-3 Supports Survival Benefit of Palbociclib Plus Fulvestrant in Advanced Breast Cancer

An updated analysis of the PALOMA-3 randomized, placebo-controlled trial demonstrated continued superiority for the combination of palbociclib (CDK4/6 inhibitor) plus fulvestrant over fulvestrant plus placebo in women with hormone receptor–positive, HER2-negative advanced breast cancer whose...

breast cancer

ADAPT Trial: ‘Excellent’ Outcomes Reported With Neoadjuvant Dual HER2 Therapy in Breast Cancer

The first overall survival analysis of the WGS-ADAPT HER2+/HR– study, which evaluated neoadjuvant therapy in patients with hormone receptor–negative, HER2-positive disease, showed that treatment with pertuzumab and trastuzumab plus paclitaxel—or with the chemotherapy-free regimen of...

hematologic malignancies

Roundup of Notable Abstracts in Hematologic Malignancies

In addition to covering the biggest news from the meeting in other articles, The ASCO Post brings you these brief news summaries of notable abstracts in multiple myeloma, lymphoma, and leukemia. Maintenance Daratumumab in Multiple Myeloma Part 2 of the CASSIOPEIA trial in 866 patients with newly...

breast cancer

Expert Point of View: Melinda Telli, MD

EA1131 study discussant, Melinda Telli, MD, Associate Professor of Medicine at Stanford University, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, commented: “At this point, capecitabine remains preferred as...

breast cancer

EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer

In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...

leukemia

Fixed-Dose, First-Line Ibrutinib/Venetoclax Combination Achieves Durable Remissions in CLL

The combination of fixed-duration, first-line treatment with ibrutinib plus venetoclax achieved complete responses in more than half of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), based on the primary analysis of the fixed-dose cohort of the phase II CAPTIVATE ...

breast cancer
genomics/genetics

Expert Point of View: Nadine M. Tung, MD

Formal discussant of the OlympiA trial, Nadine M. Tung, MD, Director of Breast Medical Oncology and the Cancer Genetics and Prevention Program at Beth Israel Deaconess Medical Center and Harvard Medical School, was enthusiastic about the ability of olaparib to improve invasive disease–free survival ...

leukemia

ELEVATE-RR Trial: Acalabrutinib as Effective as Ibrutinib, With Fewer Cardiac Effects, in Resistant CLL

Acalabrutinib was equally efficacious with less toxicity when compared directly with ibrutinib in patients with previously treated relapsed or refractory chronic lymphocytic leukemia (CLL), according to the results of an open-label, randomized, noninferiority phase III trial presented at the 2021...

breast cancer
genomics/genetics

OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer

Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...

Expert Point of View: Surbhi Sidana, MD

The session’s invited discussant Surbhi Sidana, MD, Assistant Professor of Medicine, Stanford University, said chimeric antigen receptor (CAR) T-cell therapy and bispecific antibodies targeting myeloma are emerging as potentially effective options for patients with highly refractory disease. For...

Highlights From the 2021 ASCO Annual Meeting

Despite the ongoing challenges of the COVID-19 pandemic, the practice-changing studies presented at the 2021 ASCO Annual Meeting clarified the continuing momentum in the oncology community to improve the lives of our patients.  Immunotherapy demonstrated efficacy in cancers where it had not been...

multiple myeloma

Bispecific Antibodies Advance in Relapsed or Refractory Multiple Myeloma

For the challenging population of patients with multiple myeloma who have become refractory to essentially all current treatments, new approaches are much needed. Early clinical trials data suggest bispecific antibodies may help meet this need, as suggested by studies presented at the 2021 ASCO...

Expert Point of View: Jason J. Luke, MD

Invited discussant of of the C-144-01 study,1 Jason J. Luke, MD, Associate Professor of Medicine and Director of the Cancer Immunotherapeutics Center, University of Pittsburgh Hillman Cancer Center, Pittsburgh, noted that lifileucel is “clearly an active regimen in the post–PD-1/CTLA-4 setting and...

skin cancer

Lifileucel After Disease Progression in Metastatic Melanoma: Durable Responses Achieved in Phase II Trial

Despite the fact that we have made significant progress in metastatic melanoma with immune checkpoint inhibitors—now the standard of care—most patients experience disease progression and are left without approved treatments. There is a need for newer treatments with clinical benefit. Lifileucel, an ...

skin cancer

Targeting LAG-3 and PD-1 With Relatlimab and Nivolumab: A New Option Under Study in Advanced Melanoma

Immune checkpoint inhibition has been established as an effective treatment for patients with metastatic melanoma. A novel immunotherapeutic combination—this one targeting the LAG-3 (lymphocyte-activation gene 3) and PD-1 immune checkpoints—delayed the time to disease progression significantly more ...

Expert Point of View: Kunle Odunsi, MD, PhD and Lilian T. Gien, MD, MSc

Comments on the OUTBACK trial were provided by invited discussant Kunle Odunsi, MD, PhD, Professor of Obstetrics and Gynecology, Dean for Oncology, and Director of the University of Chicago Medicine Comprehensive Cancer Center. Lilian T. Gien, MD, MSc, Associate Professor of Oncology at the...

gynecologic cancers

OUTBACK: No Benefit for Adjuvant Chemotherapy in Cervical Cancer

In women with locally advanced cervical cancer, adjuvant chemotherapy adds no benefit to standard cisplatin-based chemoradiation, results of the international phase III OUTBACK study have shown,1 as reported at the 2021 ASCO Annual Meeting by Linda R. Mileshkin, MD, Professor of Medical Oncology at ...

kidney cancer

KEYNOTE-564: Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma

Adjuvant pembrolizumab following surgery significantly improved disease-free survival compared with placebo among patients with high-risk clear cell renal cell carcinoma (RCC), according to the international phase III KEYNOTE-564 study presented at the Plenary session during the 2021 ASCO Annual...

Expert Point of View: David Cunningham, MD

David Cunningham, MD, Consultant Medical Oncologist, Head of the Gastrointestinal and Lymphoma Unit, and Director of Clinical Research at The Royal Marsden in London and Surrey in the United Kingdom, discussed CheckMate 6481 as well as the ESCORT-1st study of the PD-L1 inhibitor camrelizumab in...

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