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Lymphoma
Head and Neck Cancer
Solid Tumors
Genomics/Genetics
Gynecologic Cancers
Skin Cancer
Immunotherapy

FDA Pipeline: Novel Treatments in Lymphoma, Nasopharyngeal Cancer, Solid Tumors, and More

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for several kinds of lymphoma, as well as nasopharyngeal cancer; a Breakthrough Therapy designation for a treatment for patients with NTRK-positive advanced solid tumors; and Fast Track designation for...

Lung Cancer
Immunotherapy

Nivolumab for Relapsed Malignant Mesothelioma: Improvements in Progression-Free and Overall Survival

In the phase III CONFIRM trial reported in The Lancet Oncology, Dean A. Fennell, FRCP, PhD, and colleagues found that nivolumab improved progression-free and overall survival vs placebo in patients with relapsed malignant mesothelioma. In October 2020, the combination of nivolumab and ipilimumab...

breast cancer
immunotherapy
symptom management

Youssef Zeidan, MD, PhD, on HER2-Positive Breast Cancer: Treatment-Related Cardiotoxicity

Youssef Zeidan, MD, PhD, of Florida International University and the Lynn Cancer Institute, discusses the advances in radiotherapy planning and delivery that have reduced cardiac radiation exposure in patients with HER2-positive breast cancer who are treated with radiotherapy and trastuzumab (Abstract 12).

breast cancer
immunotherapy

Hope S. Rugo, MD, on Triple-Negative Breast Cancer: Treatment Findings From KEYNOTE-355 on Pembrolizumab and Chemotherapy

Hope S. Rugo, MD, of the University of California, San Francisco, discusses phase III results from the KEYNOTE-355 study of pembrolizumab plus chemotherapy, which improved overall survival vs chemotherapy alone in patients with previously untreated locally recurrent, inoperable, or metastatic triple-negative breast cancer whose tumors expressed PD-L1 (Abstract LBA16).

Skin Cancer
Genomics/Genetics
Immunotherapy

Expert Point of View: Omid Hamid, MD

Commenting on the SECOMBIT trial was Omid Hamid, MD, Chief of Translational Research and Immunotherapy at The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate, and Co-Director, Cutaneous Malignancy Program, Cedars-Sinai Cancer. Dr. Hamid said SECOMBIT addresses an important...

Skin Cancer
Genomics/Genetics
Immunotherapy

SECOMBIT Trial Evaluates Optimal Treatment Sequencing in BRAF-Mutated Melanoma

Patients with untreated, metastatic BRAF-mutated melanoma may benefit from receiving immunotherapy first, moving to targeted therapy in the second line, data from the updated overall survival analysis of the randomized, phase II SECOMBIT trial suggest.1 The study aimed to define the optimal...

Breast Cancer
Immunotherapy

Another Antibody-Drug Conjugate Enters the Metastatic Breast Cancer Landscape

In the global phase III TULIP trial in metastatic HER2-positive breast cancer, treatment with the antibody-drug conjugate vic-trastuzumab duocarmazine (SYD985) significantly improved progression-free survival in comparison with standard chemotherapy in previously treated patients, making this a new ...

CNS Cancers
Immunotherapy

Two Studies Examine the Efficacy of Immunotherapy for Leptomeningeal Carcinomatosis

Two new studies published in Nature Communications indicate that immunotherapy may benefit people with leptomeningeal carcinomatosis, a rare but serious complication of cancer that has spread to the brain and/or spinal cord.  Approximately 5% to 8% of all patients with cancer develop leptomeningeal ...

Multiple Myeloma
Immunotherapy

Overall Survival in the MAIA Trial: Daratumumab, Lenalidomide, and Dexamethasone for Newly Diagnosed Transplant-Ineligible Patients With Multiple Myeloma

As reported in The Lancet Oncology by Thierry Facon, MD, and colleagues, an interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to lenalidomide/dexamethasone in newly diagnosed, transplant-ineligible patients with ...

Colorectal Cancer
Immunotherapy

Nivolumab/Low-Dose Ipilimumab Produces Responses in Patients With MSI-H/dMMR Metastatic Colorectal Cancer

As reported in the Journal of Clinical Oncology by Heinz-Josef Lenz, MD, and colleagues, in the phase II CheckMate 142 trial, first-line treatment with nivolumab plus low-dose ipilimumab produced a high rate of durable responses in a cohort of patients who had received no prior treatment for...

gynecologic cancers
immunotherapy

Susana N. Banerjee, MBBS, PhD, on Ovarian, Fallopian Tube, or Primary Peritoneal Adenocarcinoma: Treatment Findings From the EORTC-1508 Trial

Susana N. Banerjee, MBBS, PhD, of The Royal Marsden NHS Foundation Trust, discusses phase II results of the EORTC-1508 trial, the first study to combine an anti–PD-L1 antibody, atezolizumab, with bevacizumab and the COX1/2 inhibitor acetylsalicylic acid as treatment for patients with ovarian, fallopian tube, or primary peritoneal adenocarcinoma (Abstract LBA32).

colorectal cancer
immunotherapy

Filippo Pietrantonio, MD, and Federica Morano, MD, on Colorectal Cancer and the MAYA Trial Strategy: Temozolomide, Ipilimumab, and Nivolumab

Filippo Pietrantonio, MD, and Federica Morano, MD, both of the Istituto Nazionale dei Tumori, discuss results from the MAYA trial, which provided proof of concept that temozolomide-induced hypermutation may be exploited to achieve durable responses to low-dose ipilimumab plus nivolumab in patients with microsatellite stable metastatic colorectal cancer (Abstract 383O).

prostate cancer
immunotherapy

Neeraj Agarwal, MD, on Advanced Prostate Cancer: Data on Cabozantinib Plus Atezolizumab

Neeraj Agarwal, MD, of Hunstman Cancer Institute at the University of Utah, discusses efficacy and safety results from the COSMIC-021 study, in which cabozantinib plus atezolizumab demonstrated clinically meaningful activity and a manageable safety profile in patients with metastatic castration-resistant prostate cancer. The findings support a phase III study of these agents vs a second line of novel hormonal therapy (Abstract LBA24).

Lung Cancer
Immunotherapy

FDA Approves Atezolizumab as Adjuvant Treatment for NSCLC

On October 15, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as...

Gynecologic Cancers
Immunotherapy

FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer

On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...

Gynecologic Cancers
Immunotherapy

Camrelizumab/Apatinib for High-Risk Chemorefractory or Relapsed Gestational Trophoblastic Neoplasia

In a Chinese single-institution phase II trial (CAP 01) reported in The Lancet Oncology, Cheng et al found that the PD-1 inhibitor camrelizumab in combination with the antiangiogenic agent apatinib produced a high rate of complete responses in women with high-risk chemorefractory or relapsed...

Lung Cancer
Immunotherapy

Neoadjuvant Atezolizumab Under Study in Mesothelioma

Neoadjuvant atezolizumab combined with pemetrexed and cisplatin, with maintenance atezolizumab, proved to be safe and feasible, offering a hint of benefit in patients with resectable pleural mesothelioma, in a small multicenter study presented at the International Association for the Study of Lung...

Skin Cancer
Immunotherapy

Expert Point of View: Omid Hamid, MD

“The U.S. Food and Drug Administration is currently examining pembrolizumab for the adjuvant treatment of stage IIB and IIC melanoma; if approved, we would be introducing immunotherapy earlier in the patient journey,” commented invited discussant Omid Hamid, MD (@OmidHamidMD), who was an...

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 ...

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