lung cancer
immunotherapy

Robert M. Jotte, MD, PhD, on NSCLC: Results From the IMpower131 Trial

Robert M. Jotte, MD, PhD, of Rocky Mountain Cancer Centers, discusses phase III study findings on atezolizumab plus carboplatin plus paclitaxel or nab-paclitaxel vs carboplatin plus nab-paclitaxel, as first-line therapy in advanced squamous non–small cell lung cancer (Abstract LBA9000).

hematologic malignancies
immunotherapy

Meletios A. Dimopoulos, MD, on Waldenström’s Macroglobulinemia

Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, discusses phase III findings on ibrutinib/rituximab vs placebo/rituximab in Waldenström’s macroglobulinemia (Abstract 8003).

lung cancer
immunotherapy

2018 ASCO: IMpower 131 Studies Addition of Atezolizumab to Chemotherapy in Advanced Squamous NSCLC

Initial findings from a randomized phase III clinical trial showed that patients with advanced squamous non–small cell lung cancer (NSCLC) benefit more from initial treatment with the programmed cell death ligand 1 (PD-L1)-targeted immunotherapy atezolizumab (Tecentriq) and chemotherapy than...

lung cancer
symptom management
immunotherapy

Safety of PD-1/PD-L1 Inhibitors in Patients With NSCLC and Preexisting Autoimmune Disorders

In a study reported in the Journal of Clinical Oncology, Leonardi et al found that programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitor monotherapy in patients with non–small cell lung cancer (NSCLC) and autoimmune disorders worsened such disorders in a...

bladder cancer
immunotherapy

FDA Identifies Efficacy Issue in Clinical Trials of Pembrolizumab or Atezolizumab as Monotherapy in Urothelial Cancer With Low Expression of PD-L1

On May 18, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with ...

Hematologic Malignancies
Immunotherapy

Logistics of CAR T-Cell Therapy in Real-World Practice

With the U.S. Food and Drug Administration (FDA) approvals of tisagenlecleucel (Kymriah)1 and axicabtagene ciloleucel (Yescarta),2 chimeric antigen receptor (CAR) T-cell therapy has moved into real-world practice, offering new potentially curative options for incurable hematologic malignancies. Its ...

lung cancer
skin cancer
issues in oncology
immunotherapy

Survival in Male vs Female Patients Receiving Immune Checkpoint Inhibitors

In a systematic review and meta-analysis reported in The Lancet Oncology, Conforti et al found a significant difference in overall survival benefit favoring male vs female patients receiving immune checkpoint inhibitor therapy for advanced cancers. Study Details The study involved database...

Lymphoma
Immunotherapy

Brentuximab Vedotin in Previously Untreated Stage III or IV Classical Hodgkin Lymphoma

On March 20, 2018, brentuximab vedotin (Adcetris) was approved for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.1,2 Supporting Efficacy Data Approval was based on the findings of the open-label phase III...

Lymphoma
Immunotherapy

Tisagenlecleucel for Adults With Relapsed or Refractory Large B-Cell Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 1, 2018, tisagenlecleucel (Kymriah), a...

Issues in Oncology
Cost of Care
Immunotherapy

Weighing the Cost and Value of CAR T-Cell Therapy

This past year’s approval by the U.S. Food and Drug Administration (FDA) of two chimeric antigen receptor (CAR) T-cell therapies heralded a new era in both effective cancer treatments and the most expensive cancer drugs ever. Tisagenlecleucel (Kymriah) was initially approved for the treatment of...

Multiple Myeloma
Immunotherapy

FDA Approves Daratumumab/VMP Combination for Newly Diagnosed Multiple Myeloma

On May 7, the U.S. Food and Drug Administration(FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for...

Symptom Management
Immunotherapy

Both Patients and Clinicians Face Challenges in Recognizing and Reporting Immune-Related Adverse Events

The publication of ASCO’s toxicity management guidelines for immune checkpoint antibodies by Brahmer and colleagues,1 reviewed in this issue of The ASCO Post, has been long awaited, considering more than 15 distinct indications have been granted by the U.S. Food and Drug Administration (FDA). The ...

Symptom Management
Immunotherapy

ASCO Clinical Practice Guideline on Managing Immune-Related Adverse Events: Next Big Step for Immune Checkpoint Inhibitors

The publication of the ASCO clinical practice guideline for the management of immune therapy–related adverse events—reviewed in this issue of The ASCO Post—represents an important next step in the incorporation of checkpoint blocking antibodies as standard cancer treatment modalities.1 The U.S....

Symptom Management
Immunotherapy

ASCO Clinical Practice Guideline: Management of Immune-Related Adverse Events From Immune Checkpoint Inhibitor Therapy

As reported in the Journal of Clinical Oncology by Julie R. Brahmer, MD, of Johns Hopkins Kimmel Cancer Center, and colleagues, ASCO has released a clinical practice guideline on management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy.1 Immune...

Solid Tumors
Immunotherapy

New Data on ALK Inhibitors and CAR T-Cell Therapies

The 2018 American Association for Cancer Research (AACR) Annual Meeting was abuzz with more than 22,000 attendees from around the world who came to Chicago to hear the latest in basic science and clinical trial results. Here we present summaries of a few of the highlights from the AACR meeting...

cns cancers
immunotherapy

Treating Pediatric Glioma With Bevacizumab and Standard Treatment

Children with nonbrainstem high-grade glioma could benefit from potentially life-extending treatment if genetic testing was used to personalize therapy as it is in many adults, new research published by Mackay et al in Cancer Cell reported.  Scientists analyzed the DNA of children taking an...

Skin Cancer
Immunotherapy

Surgery After Checkpoint Blockade for Selected Patients With Metastatic Melanoma

“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment are associated with survival of 75%, better than what has been previously reported,” Danielle M. Bello, MD, said in summarizing study results during ...

Lymphoma
Immunotherapy

FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma

On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade...

Breast Cancer
Immunotherapy

For Adjuvant Trastuzumab, 6 Months Is Noninferior to 12 Months

The noninferiority phase III Persephone trial could shake up the standard of care for adjuvant trastuzumab (Herceptin), showing that patients with early-stage HER2-positive breast cancer derived as much benefit from 6 months of trastuzumab as 12 months, according to research from the United Kingdom ...

breast cancer
immunotherapy

2018 ASCO: Shortening Adjuvant Trastuzumab to 6 Months in Patients With HER2-Positive Early Breast Cancer Is Effective and Reduces Cardiac Toxicities

Persephone, a large phase III randomized noninferiority study conducted in the United Kingdom comparing 6 months to 12 months of trastuzumab (Herceptin) in patients with HER2-positive early breast cancer has found 6 months of trastuzumab to be noninferior to 12 months of the therapy. In addition,...

Gynecologic Cancers
Immunotherapy

Microenvironment Heterogeneity May Contribute to Lack of Immunotherapy Success in High-Grade Serous Ovarian Cancer

INTER- AND INTRAPATIENT heterogeneity of the tumor microenvironment may explain the limited success of checkpoint blockade thus far observed in patients with advanced high-grade serous ovarian cancer, according to Paulina Cybulska, MD, MSc, of Memorial Sloan Kettering Cancer Center in New York....

Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab Improves Relapse-Free Survival in High-Risk Stage III Melanoma

ADJUVANT THERAPY with pembrolizumab (Keytruda) significantly prolonged recurrence-free survival compared with placebo for patients with resected high-risk stage III melanoma, according to the results of the EORTC 1325/KEYNOTE-054 trial.1 Patients who received pembrolizumab had a 43% reduction in...

Lung Cancer
Immunotherapy

Pembrolizumab Plus Standard Chemotherapy Improves Survival in Newly Diagnosed Metastatic Non–Small Cell Lung Cancer

ADDING THE IMMUNE checkpoint inhibitor pembrolizumab (Keytruda) to standard chemotherapy with pemetrexed (Alimta) and a platinum as first-line therapy was superior to chemotherapy alone in the KEYNOTE-189 trial.1 Induction and maintenance therapies with the new triplet therapy improved overall...

skin cancer
immunotherapy

Activity of T Cells From Patients With Metastatic Melanoma Resistant to Immune Checkpoint Inhibitor Treatment

In a study reported in Annals of Oncology, Andersen et al found that tumor-infiltrating lymphocytes isolated from metastatic melanoma lesions in patients with disease progression after checkpoint inhibitor therapy remain functional. Moreover, they concluded these tumor-infiltrating...

lung cancer
immunotherapy

FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous...

multiple myeloma
immunotherapy

FDA Approves Daratumumab in Combination With VMP for Newly Diagnosed Patients With Multiple Myeloma Who Are Transplant-Ineligible

On May 7, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are...

Bladder Cancer
Immunotherapy

Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma

Updated results of a phase I/II study of durvalumab (Imfinzi) in locally advanced or metastatic urothelial carcinoma were reported by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues in JAMA Oncology. Data from the ongoing study supported the recent...

Skin Cancer
Immunotherapy

Study Finds Desmoplastic Melanoma Highly Responsive to PD-1/PD-L1 Blockade

Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult, as these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of...

Skin Cancer
Immunotherapy

Nivolumab in Adjuvant Treatment of Melanoma

On December 20, 2017, nivolumab (Opdivo) was granted regular approval for adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection.1,2 Nivolumab was previously approved for the treatment of patients with unresectable or...

lung cancer
immunotherapy

IL-15 Superagonist Plus Nivolumab in Advanced NSCLC

In a phase Ib trial reported in The Lancet Oncology, Wrangle et al found evidence of activity of the combination of nivolumab (Opdivo) and the interleukin (IL)-15 superagonist ALT-803 in patients with previously treated advanced non–small cell lung cancer (NSCLC). ALT-803 targets the shared...

lung cancer
immunotherapy

FDA Accepts sBLA, Grants Priority Review for Pembrolizumab Plus Pemetrexed and Platinum Chemotherapy in Metastatic Nonsquamous NSCLC

On April 30, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) based on results of the phase III KEYNOTE-189 trial. The application seeks approval for pembrolizumab in combination with pemetrexed (Alimta) ...

lymphoma
immunotherapy

FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma

On May 1, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and...

lung cancer
immunotherapy

Results From the ARCTIC Trial in Third-Line Treatment of NSCLC

AstraZeneca and MedImmune have announced high-level results from the phase III ARCTIC trial in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who have received at least two prior treatments. This randomized, open-label, multicenter trial assessed the efficacy...

skin cancer
immunotherapy

FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations

On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar) and trametinib (Mekinist) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations (as detected by an FDA-approved test) and involvement of...

lung cancer
immunotherapy

FDA Accepts sBLA, Grants Priority Review for Nivolumab in Previously Treated Patients With SCLC

On April 18, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. ...

Skin Cancer
Immunotherapy

Immune-Related Toxicity With Combination Immunotherapy for Melanoma

As reported in JAMA Oncology by Alexander N. Shoushtari, MD, of the Memorial Sloan Kettering Cancer Center, and colleagues, a single-center experience has shown a very high rate of clinically significant immune-related adverse events with nivolumab (Opdivo) plus ipilimumab (Yervoy) for advanced...

Skin Cancer
Immunotherapy

Pembrolizumab vs Ipilimumab in Advanced Melanoma

The final overall survival analysis of the phase III KEYNOTE-006 trial showed maintained superiority of pembrolizumab (Keytruda) vs ipilimumab (Yervoy) in advanced melanoma. The results were reported by Jacob Schachter, MD, of the Ella Lemelbaum Institute for Melanoma, Sheba Medical Center, Tel...

gynecologic cancer
immunotherapy

Personalized Tumor Vaccine Shows Promise in Advanced Ovarian Cancer

A new type of cancer vaccine has yielded promising results in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and the Abramson Cancer Center of the University of Pennsylvania. The personalized vaccine is made from a patient’s own immune ...

lung cancer
immunotherapy

Pembrolizumab Monotherapy in NSCLC Meets Primary Endpoint in Phase III KEYNOTE-042 Study

On April 9, the phase III KEYNOTE-042 trial evaluating pembrolizumab (Keytruda) as monotherapy for the first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). An ...

lung cancer
immunotherapy

AACR 2018: Pilot Study of Neoadjuvant Nivolumab in Resectable NSCLC

In a pilot study reported at the 2018 American Association for Cancer Research (AACR) Annual Meeting (Abstract CT079) and in The New England Journal of Medicine by Forde et al, neoadjuvant nivolumab therapy was found to be feasible and active in patients with resectable non–small cell lung...

Lymphoma
Immunotherapy

Axicabtagene Ciloleucel CAR T-Cell Therapy Active in Refractory Large B-Cell Lymphoma

As reported at the 2017 American Society of Hematology (ASH) Meeting & Exposition and in The New England Journal of Medicine by Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, a phase II trial has shown high activity of autologous anti-CD19 chimeric...

issues in oncology
immunotherapy

AACR 2018: Boosting T-Cell Memory May Result in Longer-Lasting Responses in Patients Treated With Checkpoint Blockade Immunotherapies

Some T cells have excellent memories. These subtypes—known as memory T cells—may explain why some immunotherapies are more effective than others and could potentially lead to researchers designing more effective studies using combination checkpoint blockade treatments, according to...

skin cancer
immunotherapy

AACR 2018: Adjuvant Pembrolizumab in High-Risk Stage III Melanoma

As reported at the 2018 American Association for Cancer Research (AACR) Annual Meeting (Abstract CT001) and in The New England Journal of Medicine by Eggermont et al, the phase III EORTC 1325/KEYNOTE 054 trial has shown that adjuvant pembrolizumab (Keytruda) significantly prolonged recurrence-free...

Hematologic Malignancies
Leukemia
Immunotherapy

Fine-Tuning Treatment in Myeloma and Leukemia

It is a difficult task to include every notable presentation from the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. In addition to our more comprehensive coverage of the news from that meeting over the past several issues, below are summaries of additional key...

lung cancer
immunotherapy

AACR 2018: KEYNOTE-189: Addition of Pembrolizumab to Chemotherapy in Metastatic NSCLC

As reported at the American Association for Cancer Research (AACR) Meeting (Abstract CT075) in the The New England Journal of Medicine by Gandhi et al, the first interim analysis of the phase III KEYNOTE-189 trial has shown significant improvement in overall and progression-free survival with the...

lung cancer
immunotherapy

AACR 2018: CheckMate 227: Nivolumab/Ipilimumab vs Chemotherapy in NSCLC With High Tumor Mutational Burden Analysis

As reported at the 2018 American Association for Cancer Research (AACR) Meeting (Abstract CT077) and in The New England Journal of Medicine by Hellmann et al, an analysis from the phase III CheckMate 227 trial has shown that the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy)...

bladder cancer
immunotherapy

Health-Related Quality-of-Life Analysis of Anti–PD-1 Therapy vs Chemotherapy in Advanced Urothelial Cancer

As reported by Vaughn et al in the Journal of Clinical Oncology, a health-related quality-of-life analysis from the phase III KEYNOTE-045 trial in previously treated advanced urothelial cancer showed that patients treated with the anti–programmed cell death protein 1 immunotherapy...

solid tumors
immunotherapy

AACR 2018: Dual Inhibition of IDO1 and PD-L1 Safe in Patients With Advanced Solid Tumors

Treatment combining the IDO1 inhibitor epacadostat and the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) was found to be safe in patients with advanced solid tumors, with safety data similar to treatment with durvalumab alone, according to data presented from the ongoing...

skin cancer
immunotherapy

AACR 2018: TLR9 Agonist CMP-001/Pembrolizumab Combination Shows Early Efficacy in Patients With Metastatic Melanoma Resistant to Anti–PD-1

A combination of CMP-001, an intratumoral Toll-like receptor 9 (TLR9) agonist, and pembrolizumab (Keytruda) was well tolerated and had clinical activity in patients with metastatic melanoma resistant to programmed cell death protein 1 (PD-1) checkpoint inhibition, according to preliminary data...

Hematologic Malignancies
Lymphoma
Immunotherapy

Promise and Challenges of CAR T-Cell Therapy for Diffuse Large B-Cell Lymphoma: ZUMA-1 Trial Results

Advancing therapeutics and augmenting curability in diffuse large B-cell lymphoma (DLBCL) have been very challenging. Although many novel approaches have offered promise and continue to be developed, we have not yet identified a clearly superior approach to R-CHOP (rituximab [Rituxan],...

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