FDA Requires PD-L1 Testing Prior to Administration of Immunotherapy Agents for Urothelial Cancer
September 10th 2018The FDA now requires use of an approved companion diagnostic test to determine PD-L1 levels in the tumor tissue of cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer prescribed treatment with pembrolizumab (Keytruda) or atezolizumab (Tecentriq).
Rafametinib/Sorafenib Combo May Improve Survival in RAS-Mutated HCC
September 5th 2018<div>The combination of the MEK inhibitor refametinib and sorafenib improved overall survival and overall response rate compared with refametinib alone in patients with <em>RAS</em>-mutated hepatocellular carcinoma, according to an analysis of a pair of phase II proof-of-concept studies.</div>
Bunn Predicts Resurgence of Immunotherapy Interest in SCLC
August 31st 2018In an interview with <em>Targeted Oncology</em> prior to the FDA approval of nivolumab in SCLC, Paul A. Bunn Jr, MD, discusses the potential agents for the treatment of SCLC, the challenges in treating this patient population, and the ongoing search for biomarkers to guide treatment decisions.
Updated Guidelines Recommend HPV Test as Adequate Cervical Cancer Screening for Some
August 29th 2018New guidelines issued by the US Preventive Services Task Force recommend that women aged 30 to 65 years who are at average risk for cervical cancer can choose to receive a Pap smear alone every 3 years or screening with the high-risk human papillomavirus test alone or cotesting every 5 years.
Angiogenesis-Related Parameters Regulated by Hypoxia May Predict Poorer Survival in Metastatic RCC
August 23rd 2018The presence of biomarkers including SDF-1, VEGF-A, and sVEGFR1 and 2 at baseline were associated with poorer progression-free survival and overall survival in patients with metastatic renal cell carcinoma treated with sunitinib prior to nephrectomy.
TP53, WHSC1 Mutations Key to MCL Prognosis
August 22nd 2018Mutations of <em>TP53</em> and <em>WHSC1 </em>predicted poorer overall survival in patients with mantle cell lymphoma, according to results from next-generation whole-exome sequencing of 16 Chinese patients. The presence of these mutations may provide physicians with an important biomarker in this patient population.
Targeting EZH2 Delivers Promising Activity in Lymphomas
August 17th 2018Targeting EZH2, the catalytic subunit of the multiprotein PRC2, may represent an attractive therapeutic objective in malignant lymphoma, Vincent Ribrag, MD, told his audience at the American Association for Cancer Research’s inaugural Advances in Malignant Lymphoma meeting.
CAR-BCMA T Cells Show Promising Activity in Relapsed/Refractory Multiple Myeloma
August 2nd 2018Treatment with chimeric antigen receptor B-cell maturation antigen T cells induced substantial antitumor activity in patients with heavily treated relapsed/refractory multiple myeloma, according to results from a first-in-human clinical trial.
Trastuzumab Biosimilar Receives Approval in Europe for Breast and Gastric Cancers
August 2nd 2018The European Union has approved PF-05280014 (Trazimera), a biosimilar for trastuzumab (Herceptin), to treat patients with HER2 overexpressing metastatic or early breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Magnetic System for Guiding Lymph Node Biopsy in Breast Cancer
July 27th 2018Magtrace and Sentimag Magnetic Localization System, which uses magnetic detection to identify sentinel lymph nodes for surgical removal in women undergoing mastectomy for breast cancer, has gained approval from the FDA.
Second Filgrastim Biosimilar Granted FDA Approval
July 24th 2018Filgrastim-aafi, a filgrastim biosimilar, has been approved by the FDA to treat side effects associated with cancer treatment, including febrile neutropenia and severe neutropenia, according to an announcement from Pfizer, the manufacturer of the biosimilar.
Ibrutinib/Rituximab Combo Induces 3-Year OS of 69% in Relapsed/Refractory MCL
July 19th 2018The combination of ibrutinib (Imbruvica) and rituximab (Rituxan) produced durable remissions in patients with relapsed/refractory mantle cell lymphoma, according to 4-year follow-up results from a single-arm phase II clinical trial.
Older Age Correlates With Better Response to Anti-PD-1 Therapy in Melanoma
July 18th 2018Patients aged ≥62 years with melanoma were more likely to respond to treatment with pembrolizumab than younger patients, according to results published in <em>Clinical Cancer Research. </em>Investigators at The Wistar Institute in Philadelphia concluded that the risk for progression following anti–PD-1 therapy declined by 13% with each decade of life.
Drake Discusses CARMENA Results and Evolving Treatment Landscape in RCC
July 13th 2018Sunitinib alone was noninferior for median overall survival compared with sunitinib plus cytoreductive nephrectomy in patients with synchronous metastatic renal cell carcinoma, according to findings from the phase III noninferiority CARMENA trial.
Obinutuzumab Appears Safe, Effective in Relapsed/Refractory CLL
July 12th 2018An updated analysis of obinutuzumab alone or in combination with chemotherapy for patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia detected no new safety signals. Investigators in the phase IIIb GREEN trial also found overall response rates greater than 80% at 3 months post-treatment in some patients.
Promising Activity Seen With Palbociclib/Cetuximab Combo in HPV-Unrelated HNSCC
July 12th 2018An overall response rate of 39% was induced with the combination of the CDK4/6 inhibitor palbociclib and cetuximab in patients with platinum-resistant, HPV-unrelated recurrent/metastatic head and neck squamous cell carcinoma.
Analysis Shows Incidence of Cardiovascular Toxicities Associated With ICIs
July 3rd 2018Immune checkpoint inhibitors, alone or in combination, are associated with increased incidence of some cardiovascular toxicities in patients with cancer, according to results from a cross-trial pooled analysis presented in a poster at the 2018 ASCO Annual Meeting.
Regorafenib Doubles 12-Month Survival Compared with Lomustine in Recurrent GBM
June 28th 2018Regorafenib (Stivarga) improved overall survival and progression-free survival compared with lomustine (Gleostine) for patients with glioblastoma that recurred following surgery and treatment with the Stupp regimen, according to updated results presented in a poster at the 2018 ASCO Annual Meeting.
SL-701 Demonstrates Antitumor Activity in Relapsed/Refractory GBM
June 27th 2018The anticancer immunotherapy vaccine SL-701, when used with immunostimulants, induced antitumor activity in patients with relapsed/refractory glioblastoma both alone and in combination with bevacizumab, according to updated phase II results from the 2-stage STML-701-0114 trial presented at the 2018 ASCO Annual Meeting.
Evolving Adjuvant Treatment Landscape in GI Cancers
June 26th 2018Things are looking up in the world of adjuvant therapy for patients with gastrointestinal cancers, according to Diane Reidy-Lagunes, MD. During her presentation, Reidy-Lagunes outlined the current state-of-the-art in GI cancer care, with findings from pivotal studies in gastric, pancreatic, biliary, and colorectal cancers.
Novel Assay Identifies Molecular Subtypes in MCL
June 21st 2018The 16-gene Leukemic-MCL16 (L-MCL16) Assay reliably distinguished between classic and indolent mantle cell lymphoma subtypes in patients with leukemic presentation, according to results published in <em>Blood</em>. Combined with genomic complexity, the assay was prognostic for overall survival.
Breaking Down CDK4/6 Resistance in ER+/ HER2- Breast Cancer
June 20th 2018Multiple pivotal studies have led to CDK4/6 inhibitors such as ribociclib, abemaciclib, and palbociclib becoming the standard of care for women with metastatic ER-positive/HER2-negative breast cancer. Speaking at the 11th European Breast Cancer Conference in Barcelona, Spain, Nicholas C. Turner, MD, PhD, a consultant medical oncologist with The Royal Marsden Hospital NHS Trust, explained how tumors resist treatment with CDK4/6 inhibitors and how that resistance can be overcome.
Tucatinib Demonstrates Activity in Heavily Pretreated HER2+ Breast Cancer
June 20th 2018Promising antitumor activity was seen in patients with heavily pretreated HER2-positive breast cancer with or without brain metastases with the use of tucatinib in combination with capecitabine, trastuzumab, or both agents, according to phase Ib findings published in <em>The Lancet Oncology</em>.
Pembrolizumab Survival Benefit in Melanoma Sustained at 4 Years
June 19th 2018Pembrolizumab (Keytruda) induced a median overall survival (OS) of 32.7 months versus 15.9 months for ipilimumab (Yervoy) in patients with unresectable stage III-IV melanoma, according to 4-year survival results from the KEYNOTE-006 trial presented at the 2018 ASCO Annual Meeting.
Lenvatinib/Pembrolizumab Combo Shows Early Promising Activity in Unresectable HCC
June 13th 2018The combination of the VEGFR/FGFR inhibitor lenvatinib and the PD-1 inhibitor pembrolizumab induced a confirmed overall response rate of 26.9% (95% CI, 11.6%-47.8%) in patients with unresectable hepatocellular carcinoma, according to results from a 2-part, phase Ib trial.
Indication for Scalp Cooling System Expanded by FDA to Include All Solid Tumors
June 13th 2018The indication for the Orbis Paxman Hair Loss Cooling System has been expanded by the FDA to include the prevention of chemotherapy-related alopecia in patients with solid tumors, according to Paxman, the maker of the device. The system was previously approved to treat chemotherapy-related alopecia in patients with breast cancer.
Over-the-Counter Chemoprevention Strategy Reduces Risk for Esophageal Cancer
June 5th 2018According to updated findings from the phase III ASPECT trial presented at the 2018 ASCO Annual Meeting, a combination of 2 over-the-counter drugs can reduce the risk for high-grade dysplasia or esophageal cancer in patients with Barrett’s esophagus if taken for at least 7 years. These results also demonstrated that high-dose esomeprazole in combination with a low-dose aspirin was associated with delaying all-cause mortality.
Sunitinib Alone Shows Noninferiority Versus Standard of Care in mRCC
June 4th 2018According to findings from the phase III CARMENA trial presented at the 2018 ASCO Annual Meeting, sunitinib monotherapy demonstrated noninferiority compared with cytoreductive nephrectomy in combination with sunitinib in patients with synchronous metastatic renal cell carcinoma.