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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,...

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 ...

Lung Cancer
Immunotherapy

Atezolizumab Plus Chemotherapy in Patients With Advanced NSCLC and Brain Metastases

Patients with advanced non–small cell lung cancer (NSCLC) and brain metastases derived benefit from treatment with atezolizumab plus chemotherapy, according to findings from the multicenter phase II ATEZO-BRAIN/GECP 17/05 trial. The study was presented at the International Association for the Study ...

Gynecologic Cancers
Immunotherapy

Nivolumab vs Gemcitabine or Pegylated Liposomal Doxorubicin: What Regimen Improves Survival in Platinum-Resistant Ovarian Cancer?

In a Japanese phase III trial (NINJA) reported in the Journal of Clinical Oncology, Hamanishi et al found that nivolumab did not improve overall survival vs chemotherapy with either gemcitabine or pegylated liposomal doxorubicin in platinum-resistant epithelial ovarian cancer. Study Details In the...

lung cancer
immunotherapy

Prasad S. Adusumilli, MD, on CAR T-Cell Therapy for Mesothelioma

Prasad S. Adusumilli, MD, of Memorial Sloan Kettering Cancer Center, discusses phase I/II research he is conducting on CAR T cells delivered intrapleurally in patients with mesothelioma. The treatment is targeting mesothelin, a cancer cell-surface antigen overexpressed in many solid tumors and associated with aggressive disease (Abstract PL05.01).

Lung Cancer
Immunotherapy

Neoadjuvant Atezolizumab Under Study for Resectable Pleural Mesothelioma

Neoadjuvant atezolizumab combined with pemetrexed and cisplatin, followed by surgical resection and maintenance atezolizumab, proved safe and feasible and offered hints of benefit in patients with resectable pleural mesothelioma. Results from a small multicenter study were presented by Boris...

Lung Cancer
Immunotherapy

Maintenance Durvalumab: Increased Utilization Could Improve NSCLC Outcomes

Maintenance durvalumab—the recommended maintenance treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC) following chemoradiation—remains significantly underutilized, according to research presented by Liu et al at the International Association for the Study of Lung...

Leukemia
Immunotherapy

AUTO1: CAR T-Cell Product for Adult Patients With Relapsed or Refractory B-Cell ALL

In a phase I trial (ALLCAR19) reported in the Journal of Clinical Oncology, Roddie et al found that the fast off-rate autologous CD19 chimeric antigen receptor (CAR) T-cell therapy CAT19-41BB-Z—also known as AUTO1—was well tolerated and produced high remission rates in adults with relapsed or...

Lung Cancer
Immunotherapy

POSEIDON Trial: Dual Checkpoint Blockade Plus Chemotherapy Improves Survival in First-Line Metastatic NSCLC

Findings from the phase III POSEIDON trial showed significantly improved progression-free and overall survival in patients with metastatic non–small cell lung cancer (NSCLC) who received first-line durvalumab and tremelimumab plus chemotherapy vs chemotherapy alone. These findings were presented by ...

Lung Cancer
Immunotherapy

IMpower010 Study of Atezolizumab in Resectable NSCLC: Benefits Observed Regardless of Stage, Type of Prior Treatment

In an exploratory analysis of the pivotal phase III IMpower010 trial—which found that adjuvant atezolizumab significantly improved disease-free survival in resectable non–small cell lung cancer (NSCLC)—benefit was shown regardless of the type of surgery or the chemotherapy doublet received by the...

Immunotherapy
Symptom Management

Technology-Enabled Monitoring of Adverse Reactions to Immune Checkpoint Inhibitors

In an interim analysis of a single-institution study reported in JAMA Network Open, Pavlos Msaouel, MD, PhD, and colleagues found that the use of a mobile device application for patient reporting of adverse reactions to immune checkpoint inhibition was feasible. It permitted identification of...

Multiple Myeloma
Immunotherapy

Treatment of Relapsed Myeloma: Options Include New Drugs, Novel Combinations

The treatment paradigm for multiple myeloma continues to evolve at a rapid pace with the introduction of new drugs and the development of drug combinations, particularly the initial approach to the treatment of newly diagnosed multiple myeloma.1 One major shift in the treatment of newly diagnosed...

Multiple Myeloma
Immunotherapy

Subcutaneous Daratumumab Added to Pomalidomide Plus Dexamethasone Improves Progression-Free Survival in Multiple Myeloma

As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous (SC) daratumumab to oral...

Immunotherapy
Gastroesophageal Cancer

Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...

Breast Cancer
Immunotherapy

Pembrolizumab for High-Risk, Early-Stage Triple-Negative Breast Cancer

On July 26, 2021, pembrolizumab was approved for high-risk, early-stage, triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and continued as adjuvant treatment.1 Pembrolizumab was also granted regular approval in combination with chemotherapy for locally...

Lymphoma
Immunotherapy

Assumptions, Data … and More Questions!

I read with great interest the results from the phase II ZUMA-12 study of axicabtagene ciloleucel, presented during the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 But the results raised several questions for me. Axicabtagene ciloleucel, an autologous anti-CD19...

Immunotherapy
Geriatric Oncology

Biomarker Analysis Evaluates Potential for Immune Checkpoint Blockade Response in Older Patients With Cancer

A retrospective analysis of large data sets of biomarkers from tumors and healthy tissue by researchers at the Johns Hopkins Kimmel Cancer Center Convergence Institute suggests that older patients with cancer may benefit as much from cancer immunotherapies as younger patients. The findings,...

Lung Cancer
Immunotherapy

Several Studies Show Rovalpituzumab Tesirine Is Ineffective Against SCLC

Four independent studies published in the Journal of Thoracic Oncology demonstrate that rovalpituzumab tesirine (Rova-T), a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3), is not effective against small cell lung cancer (SCLC). An accompanying editorial by...

Skin Cancer
Immunotherapy

Phase II Trial Evaluates Oncolytic Coxsackievirus A21 for Unresectable Advanced Melanoma

In a phase II trial reported in the Journal of Clinical Oncology, Robert H.I. Andtbacka, MD, and colleagues found that intratumoral injection of the oncolytic RNA virus Coxsackievirus A21 (V937) was well tolerated and produced responses in some patients with unresectable stage III or stage IV...

Bladder Cancer
Immunotherapy

Neoadjuvant Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab for Muscle-Invasive Bladder Cancer

In a phase II study reported in the Journal of Clinical Oncology, Tracy L. Rose, MD, MPH, and colleagues found that neoadjuvant therapy with pembrolizumab, gemcitabine, and primarily split-dose cisplatin resulted in pathologic downstaging (< pT2N0) in more than half of patients undergoing...

Skin Cancer
Immunotherapy

Pembrolizumab/Entinostat for Metastatic Uveal Melanoma

In the phase II PEMDAC study, researchers showed that the combination of the PD-1 inhibitor pembrolizumab and the histone deacetylase (HDAC) inhibitor entinostat resulted in durable responses in a small group of patients with metastatic uveal melanoma. These findings were published by Ny et al in...

Bladder Cancer
Immunotherapy

FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma

On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label...

Breast Cancer
Immunotherapy

Evandro de Azambuja, MD, PhD, Comments on the BERENICE Trial

The invited discussant for the BERENICE trial was Evandro de Azambuja, MD, PhD, Head of the Medical Support Team at the Institut Jules Bordet in Brussels. He concluded from the study that pertuzumab plus trastuzumab, combined with an anthracycline/taxane regimen given every 2 weeks or every 3...

Breast Cancer
Immunotherapy

Safety, Efficacy of Neoadjuvant Pertuzumab Plus Trastuzumab Maintained in Final Analysis of BERENICE Trial

Long-term cardiac safety and efficacy have been confirmed for pertuzu­mab plus trastuzumab in patients with early breast cancer, in an update of the phase II BERENICE trial reported at the 2021 ESMO Breast Cancer Virtual Congress.1 Chau T. Dang, MD, of the Breast Medicine Service at Memorial Sloan...

Gastroesophageal Cancer
Immunotherapy

Addition of Pembrolizumab to Chemotherapy for the First-Line Treatment of Advanced Esophageal Cancer: KEYNOTE-590

As reported in The Lancet by Sun et al, the phase III KEYNOTE-590 trial showed that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free survival in patients with advanced esophageal and Siewert type 1 gastroesophageal junction (GEJ) cancers....

Lung Cancer
Immunotherapy

Study Highlights Gaps Between Lung Cancer Treatment Recommendations and Real-World Use of Durvalumab

A recent study published by Ronden et al in JTO Clinical and Research Reports highlights the gap between treatment guidelines and real-world care with the monoclonal antibody durvalumab for patients with non–small cell lung cancer. Researchers studied treatment decision-making by three Dutch...

Breast Cancer
Immunotherapy

Update on U.S. Indication for Atezolizumab in PD-L1–Positive Metastatic Triple-Negative Breast Cancer

Genentech, a member of the Roche Group, announced that it has made the decision to voluntarily withdraw the U.S. accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast...

Immunotherapy

Profile of Adverse Events Related to PD-1 and PD-L1 Inhibitor–Based Therapy

In a systematic review and meta-analysis reported in The Lancet Oncology, Zhou et al provided a profile of treatment-related adverse events observed in clinical trials combining PD-1 or PD-L1 inhibitors with chemotherapy, targeted therapy, immunotherapy, and radiotherapy. Study Details The...

Breast Cancer
Immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Triple-Negative Breast Cancer

On April 7, 2021, sacituzumab govitecan-hziy was granted regular approval for treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.1 Sacituzumab...

Bladder Cancer
Immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Urothelial Cancer

On April 13, 2021, sacituzumab govitecan-hziy was granted accelerated approval to treat patients with locally advanced or metastatic urothelial cancer who had received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.1 Supporting Efficacy Data Approval was based on findings...

Hematologic Malignancies
Head and Neck Cancer
Gynecologic Cancers
Immunotherapy
Symptom Management

FDA Pipeline: Reviews for Agents in Acute Graft-vs-Host Disease, Nasopharyngeal and Ovarian Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to an agent for the prevention of acute graft-vs-host disease; Breakthrough Therapy designation to an anti–PD-1 monoclonal antibody for the treatment of metastatic nasopharyngeal carcinoma; and Fast Track designation to a ...

Skin Cancer
Immunotherapy

Patients With Melanoma Previously Treated With PD-1 or MAPK Inhibitors May Be Less Likely to Respond to ACT-TIL Therapy

Patients with metastatic melanoma who were previously treated with PD-1 or MAPK inhibition are significantly less likely to develop durable objective responses to adoptive cell transfer of tumor-infiltrating lymphocytes (ACT-TIL) than patients naive to these treatments, according to a study...

Kidney Cancer
Immunotherapy

Adjuvant Pembrolizumab May Improve Disease-Free Survival in Patients With High-Risk Renal Cell Carcinoma

As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, and colleagues, an interim analysis of the phase III KEYNOTE-564 trial showed improved disease-free survival with adjuvant pembrolizumab vs placebo after nephrectomy in high-risk patients with clear cell renal cell...

Bladder Cancer
Immunotherapy

FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma

On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant...

Leukemia
Immunotherapy

Outcomes Notably Improving for Adult ALL

Outcomes in adults with acute lymphoblastic leukemia (ALL) are almost rivaling those in pediatric ALL, thanks to the benefits achieved by incorporating blinatumomab and inotuzumab into chemotherapy regimens. New ways of administering the chemotherapy component are also increasing tolerability and...

Lung Cancer
Immunotherapy

Does Antibiotic Exposure Affect Response to First-Line Chemoimmunotherapy in Patients With NSCLC?

In an international, multicenter study, researchers evaluated the impact of prior and concurrent antibiotic exposure in a cohort of patients with advanced non–small cell lung cancer (NSCLC) treated with first-line chemoimmunotherapy combinations. In contrast to what has been reported in patients...

Colorectal Cancer
Genomics/Genetics
Immunotherapy

Cetuximab Plus Avelumab as Rechallenge Therapy for RAS Wild-Type Metastatic Colorectal Cancer

In an Italian phase II trial reported in JAMA Oncology, Martinelli et al found that cetuximab rechallenge plus avelumab showed activity and was well tolerated in patients with RAS wild-type metastatic colorectal cancer who had responded to first-line chemotherapy plus an anti-EGFR agent and then...

Colorectal Cancer
Immunotherapy

Eric Deutsch, MD, PhD, Comments on the Averectal and AVANA Trials in Rectal Cancer

Eric Deutsch, MD, PhD, Professor and Chair of Radiation Oncology at Gustave Roussy, Villejuif, France, commended the speakers for conducting trials whose results he found “very interesting.” The Averectal trial involved a short course of radiation with modified FOLFOX-6 (oxaliplatin, fluorouracil...

Colorectal Cancer
Immunotherapy

Avelumab Under Study as Adjunct to Neoadjuvant Therapy for Rectal Cancer

In the treatment of newly diagnosed locally advanced rectal cancer, two phase II studies evaluating the addition of the PD-L1 inhibitor avelumab to chemoradiotherapy showed promising rates of pathologic complete response, major pathologic response, and tumor downstaging. The study investigators...

Leukemia
Immunotherapy

Donor-Derived CD7 CAR T Cells May Lead to Remissions in Patients With Relapsed or Refractory T-ALL

In a Chinese single-institution phase I study reported in the Journal of Clinical Oncology, Pan et al found that donor-derived CD7 chimeric antigen receptor (CAR) T-cell therapy produced a high complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia...

Leukemia
Immunotherapy

Experimental Small-Molecule Inhibitor May Improve Responses to Cellular Therapies in Advanced CLL

Too many “exhausted” T cells left in the wake of aggressive chemotherapy regimens for patients with advanced chronic lymphocytic leukemia (CLL) make it more challenging for chimeric antigen receptor (CAR) T-cell therapy to do its job. Now, a new study from researchers at the Perelman School of...

Solid Tumors
Immunotherapy

FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors

On August 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli), an anti–PD-1 antibody, for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, who have had disease...

Breast Cancer
Immunotherapy

Study Identifies Potential Mechanisms of Resistance to Sacituzumab Govitecan-hziy in Patients With Triple-Negative Breast Cancer

Researchers have determined how a highly aggressive type of breast cancer may evade treatment with the compound sacituzumab govitecan-hziy, according to findings published by Coates et al in Cancer Discovery. Their results could help improve therapy and ultimately prolong survival for patients with ...

Sarcoma
Immunotherapy

Small Study Evaluates Combination Ipilimumab/Nivolumab in Patients With Angiosarcoma

In a small study of 16 patients with angiosarcoma published by Michael Wagner, MD, and colleagues in the Journal for ImmunoTherapy of Cancer, 4 patients experienced a partial or complete response to treatment with a combination of the immunotherapies ipilimumab and nivolumab, and another 2 patients ...

lymphoma
immunotherapy

Steven M. Horwitz, MD, on Advanced-Stage Mycosis Fungoides and Sezary Syndrome: Update on Management Practices

Steven M. Horwitz, MD, of Memorial Sloan Kettering Cancer Center, discusses treatments for advanced mycosis fungoides and Sezary syndrome, including brentuximab vedotin and mogamulizumab, and how best to choose among treatments.

lymphoma
immunotherapy

James O. Armitage, MD, on Advanced Hodgkin Lymphoma: Choosing Among BEACOPP, A-AVD, and Checkpoint Inhibitors

James O. Armitage, MD, of the University of Nebraska Medical Center, discusses various treatment regimens for patients with Hodgkin lymphoma, including BEACOPP, brentuximab vedotin, ABVD, A-AVD, nivolumab, and pembrolizumab—and the factors to consider when choosing among them.

lymphoma
immunotherapy

Bruce D. Cheson, MD, and Stephen M. Ansell, MD, PhD, on Non-Hodgkin and Follicular Lymphomas: Integrating Non–CAR T-Based Treatments

Stephen M. Ansell, MD, PhD, of the Mayo Clinic, and Bruce D. Cheson, MD, of the Lymphoma Research Foundation, engage in a lively debate about CAR T-cell therapy, how it fits in with immunotherapy and nonchemotherapy approaches, and how to decide which treatment is right for which patient, especially given the many challenges of obtaining CAR T cells.

lymphoma
immunotherapy

Alison J. Moskowitz, MD, on ABVD in Hodgkin Lymphoma: Adding Brentuximab Vedotin and Checkpoint Inhibitors to Standard Treatment

Alison J. Moskowitz, MD, of Memorial Sloan Kettering Cancer Center, discusses the combination ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine), individualized approaches for treating patients with Hodgkin lymphoma, and novel methods for risk stratification.

hematologic malignancies
leukemia
immunotherapy

Alexey V. Danilov, MD, PhD, on Lymphoid Malignancies: Novel Agents Targeting BTK Inhibitor–Resistant Disease

Alexey V. Danilov, MD, PhD, of City of Hope, discusses the uses and side effects of cellular and immune therapies, including venetoclax and obinutuzumab, which may prove to be effective in treating highly resistant lymphoid malignancies such as chronic lymphocytic leukemia.

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