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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 ...
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...
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...
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...
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...
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...
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 ...
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....
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...
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...
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...
“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 ...
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...
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 ...
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,...
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....
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...
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...
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...
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...
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...
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...
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...
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...
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...
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) ...
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...
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...
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...
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. ...
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...
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...
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 ...
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 ...
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...
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...
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...
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...
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...
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...
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)...
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...
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...
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...
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],...
How should clinicians position anti-HER2 agents and also incorporate endocrine therapies in the treatment of metastatic HER2-positive breast cancer? At the 2018 Miami Breast Cancer Conference, this question was explored by Sunil Verma, MD, Medical Director of the Tom Baker Cancer Center and...
On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab (Opdivo) and ipilimumab (Yervoy) in combination for the treatment of intermediate- or poor-risk previously untreated advanced renal cell carcinoma (RCC). CheckMate 214 The approvals were based on...
FT819—an off-the-shelf, T-cell receptor–less CD19 chimeric antigen receptor (CAR) T-cell product that could potentially be made more accessible to patients with cancer than conventional CAR T-cell therapies—showed positive results in preclinical specificity, functionality, and...
Further evidence that immunotherapy provides long-term survival benefit for patients with lung cancer was presented by Mazières et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract 136PD_PR). Researchers presented the 3-year survival results of the randomized...
In an Australian phase II trial reported in The Lancet Oncology, Long et al found that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) and nivolumab alone showed intracranial activity in patients with melanoma brain metastases. Study Details In the open-label trial, 76 evaluable...