Breaking News
December 14, 2018 - Blood test helps identify distinct molecular signatures in children with cystic fibrosis
December 14, 2018 - Scientists use water to track electrical activity of nerve cells
December 14, 2018 - Recurrence of urinary tract infection may depend on bacterial strain, study shows
December 14, 2018 - GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA)
December 14, 2018 - Partial Thromboplastin Time (PTT) Test: MedlinePlus Lab Test Information
December 14, 2018 - Common tactics for health promotion at work may be detrimental to employees with obesity
December 14, 2018 - Myths about migration and health not supported by available evidence
December 14, 2018 - Recent findings on rare genetic disorder may help develop new treatment options
December 14, 2018 - New drug shows promise in treating sarcomas
December 14, 2018 - Scientists perform lung lavage as new approach for tuberculosis diagnosis in rhinoceros
December 14, 2018 - Recent winners of the Nobel Medicine Prize
December 14, 2018 - KHN’s ‘What the Health?’ Insurance enrollment is lagging — and there are lots of reasons why
December 14, 2018 - Study assesses safety and efficacy of new treatment for pancreatic cancer
December 14, 2018 - Study finds drug targets for Ebola, Dengue, and Zika viruses
December 14, 2018 - Study highlights need for personalized approach to treat ICU acquired delirium
December 14, 2018 - Soot particles from road traffic significantly contribute to air pollution
December 14, 2018 - Massage helps relieve pain, improve mobility in patients with knee osteoarthritis
December 14, 2018 - Researchers explore home healthcare nurses’ knowledge attitudes toward infection control
December 14, 2018 - Average outpatient visit in the U.S. costs nearly $500, shows new study
December 14, 2018 - Reference Infliximab, Biosimilar Equivalent for Crohn’s Disease
December 14, 2018 - New contact lens to treat eye injuries
December 14, 2018 - Acne could have a genetic basis find researchers promising new cure
December 14, 2018 - Higher physical activity associated with improved mood
December 14, 2018 - New UGA study points to optimal hypertension treatment for stroke patients
December 14, 2018 - Study highlights factors that can reduce food cravings
December 14, 2018 - Researchers discover Ebola-fighting protein in human cells
December 14, 2018 - Fentanyl surpasses heroin in cause of U.S. drug overdose deaths
December 14, 2018 - When Heart Attack Strikes, Women Often Hesitate to Call for Help
December 14, 2018 - A warning about costume contacts
December 14, 2018 - Study examines link between peripheral artery disease and heart attack
December 14, 2018 - Researchers develop biotechnological tool to produce antifungal proteins in plants
December 14, 2018 - 3D-printed adaptive aids can benefit patients with arthritis
December 14, 2018 - Chronic bullying during adolescence impacts mental health
December 14, 2018 - Integral Molecular and Merus collaborate to develop bispecific antibody therapeutics
December 13, 2018 - Importance of cell cycle and cellular senescence in the placenta discovered
December 13, 2018 - Gold “nanoprisms” open new window into vessels and single cells
December 13, 2018 - Research findings could lead to new targets for cancer-fighting therapeutics
December 13, 2018 - Butantan Institute signs collaboration agreement with MSD to develop dengue vaccines
December 13, 2018 - Study explores how patients want to discuss symptoms with doctors
December 13, 2018 - RUDN medics first to gather scattered data on hepatitis morbidity in Somalia
December 13, 2018 - Age and gender disparities found in use of bed nets to prevent malaria in sub-Saharan Africa
December 13, 2018 - Caffeine therapy benefits developing brains of premature babies
December 13, 2018 - New review focuses on electrospinning techniques used in musculoskeletal tissue engineering
December 13, 2018 - A new division focused on human immune system
December 13, 2018 - Zogenix Announces Positive Phase 3 Trial Results on the Efficacy and Safety of Fintepla (ZX008) in Dravet Syndrome
December 13, 2018 - BCR ABL Genetic Test: MedlinePlus Lab Test Information
December 13, 2018 - Caffeinated beverages during pregnancy linked to lower birth weight babies
December 13, 2018 - Stanford Medicine Health Trends Report examines opportunity to democratize health care
December 13, 2018 - Obsessive-compulsive disorder may protect individuals from obesity
December 13, 2018 - Scientists investigate how a painful event is processed in the brain
December 13, 2018 - Genetic study reveals new insights into underlying causes of moderate-to-severe asthma
December 13, 2018 - Study uncovers new genetic clues to frontotemporal dementia
December 13, 2018 - Vitamin C supplementation for pregnant smokers may reduce harm to infants’ lungs
December 13, 2018 - New study reveals yin-yang personality of dopamine
December 13, 2018 - Research identifies nerve-signaling pathway behind sustained pain after injury
December 13, 2018 - Children with high levels of callous traits show widespread differences in brain structure
December 13, 2018 - Long-term Benefit of Steroid Injections for Knee Osteoarthritis Challenged
December 13, 2018 - Adding new channels to the brain remote control
December 13, 2018 - In the Spotlight: A different side of neuroscience
December 13, 2018 - Medical Marvels: Using immunotherapy for melanoma that spread to the brain
December 13, 2018 - Puzzles do not keep dementia away finds study
December 13, 2018 - New mouse model shows potential for rapid identification of promising muscular dystrophy therapies
December 13, 2018 - Study reveals urban and rural differences in prenatal exposure to essential and toxic elements
December 13, 2018 - New collaborative partnership in quest of novel antibiotics
December 13, 2018 - Single tau molecule holds clues to help diagnose neurodegeneration in its earliest stages
December 13, 2018 - AHA Scientific Statement: Low Risk of Side Effects for Statins
December 13, 2018 - What Is Acute Flaccid Myelitis?
December 13, 2018 - How bereaved people control their thoughts without knowing it
December 13, 2018 - Health care democratization underway, according to 2nd annual Stanford Medicine Health Trends Report | News Center
December 13, 2018 - Going Beyond a Single Color
December 13, 2018 - London-based startup launches ‘thedrug.store’ aiming to clean up CBD industry
December 13, 2018 - Loss of tight junction barrier protein results in gastric cancer development
December 13, 2018 - Novel way to efficiently deliver anti-parasitic medicines
December 13, 2018 - RKI publishes new data on disease prevention and utilization of medical services
December 13, 2018 - High-tech, flexible patches sewn into clothes could help to stay warm
December 13, 2018 - The CCA releases three reports on requests for medical assistance in dying
December 13, 2018 - Restoring Hair Growth on Scarred Skin? Mouse Study Could Show the Way
December 13, 2018 - Probiotic use may reduce antibiotic prescriptions, researchers say
December 13, 2018 - Drug repositioning strategy identifies potential new treatments for epilepsy
December 13, 2018 - Chronic rhinitis associated with hospital readmissions for asthma and COPD patients
Combo Bests Targeted Agent in mRCC

Combo Bests Targeted Agent in mRCC

image_pdfDownload PDFimage_print

Action Points

  • Note that this study was published as an abstract and will be presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

SAN FRANCISCO — Patients with newly diagnosed metastatic renal cell carcinoma (mRCC) lived about 3 months longer without disease progression with immunotherapy-based treatment rather than a targeted agent, a randomized trial showed.

In the subgroup of patients with PD-L1 positive tumors, initial treatment with atezolizumab (Tecentriq) and bevacizumab (Avastin) led to a median progression-free survival (PFS) of 11.2 months compared with 7.7 months for patients who received standard first-line treatment with sunitinib (Sutent). The intention-to-treat population had a median PFS of 11.2 months with the combination and 8.4 months with sunitinib, according to Robert Motzer, MD, of Memorial Sloan Kettering Cancer Center in New York City, and colleagues.

Median overall survival (OS) in the ITT population had yet to be reached, but trended in favor of the atezolizumab-bevacizumab arm. Additionally, more patients had objective responses with the combination, Motzer reported at a press briefing prior to the Genitourinary Cancers Symposium (GUCS).

“The response outcomes and encouraging immature overall survival results support improved efficacy for atezolizumab plus bevacizumab in patients with PD-L1 positive disease,” said Motzer. “Atezolizumab and bevacizumab had fewer high-grade treatment-related adverse events, low steroid use, and delayed symptom interference with daily life versus sunitinib.

“These study results support the consideration of atezolizumab and bevacizumab as a first-line treatment option for PD-L1 positive patients with advanced renal cell carcinoma.”

The results “represent an important breakthrough in cancer therapy,” said press briefing moderator Sumanta Pal, MD, of City of Hope in Duarte, California. For several years, oncologists have debated the relative merits of immunotherapy and targeted therapy as the preferred treatment for advanced RCC.

“This study, which is the first of its kind, points to a combination of both as being highly effective in delaying cancer growth, and there’s also an early trend toward improving survival,” said Pal. “The higher rate of complete response with bevacizumab and atezolizumab was also very encouraging. Achieving a complete response — total eradication of metastatic disease — is really the highest bar that we can strive for in this setting.”

Tolerability with the combination of targeted and immune therapies is another important piece of information from the study, he added. The side effect profile appeared to be superior, in some respects, to that of oral targeted agents used in the setting of mRCC.

“I would agree with Dr. Motzer that the data support consideration of atezolizumab and bevacizumab as a first-line option,” said Pal.

The trial involved 915 patients with previously untreated mRCC. Investigators in the international multicenter trial randomized the patients to the combination of atezolizumab and bevacizumab or to sunitinib, which has been standard of care as first-line therapy for mRCC for the past decade, Motzer noted. About 40% of the patients tested positive for PD-L1 expression, defined as >1% expression on tumor-infiltrating immune cells.

The trial had co-primary endpoints of investigator-assessed PFS in the PD-L1 positive subgroup and OS in the ITT population. Secondary endpoints included PFS in the ITT population, objective response rate, and duration of response.

Motzer reported findings from an analysis performed after a median follow-up of 15 months. The 3.5-month difference in PFS in the PD-L1 positive group was associated with a hazard ratio of 0.74 in favor of the atezolizumab-bevacizumab combination (95% CI 0.57-0.96, P=0.0217). Immature survival data showed a 19% reduction in the HR in favor of the combination, although the median had yet to be reached in either arm (95% CI 0.63-1.03, P=0.09).

Other endpoints consistently favored the combination treatment:

  • PFS (ITT): 11.2 versus 8.4 months (HR 0.83, 95% CI 0.70-0.97, P=0.02)
  • Survival (PD-L1+): Not reached versus 23.3 months (HR 0.68, 95% CI 0.46-1.00, P=0.05)
  • Confirmed Response (PD-L1+): 43% versus 35%
  • Confirmed Response (ITT): 37% versus 33%
  • Complete Response (PD-L1+): 9% versus 4%
  • Complete Response (ITT): 5% versus 2%

The combination of an immune checkpoint inhibitor and angiogenesis inhibitor resulted in a better safety profile. Patients randomized to sunitinib had higher rates of diarrhea, palmar/plantar erythrodysesthesia, hypertension, fatigue, dysgeusia, decreased appetite, mucositis, stomatitis, asthenia, and vomiting. The combination was associated with more proteinuria. Motzer reported that 16% of patients in the combination arm required systemic steroids to manage adverse events.

The safety and efficacy of atezolizumab and bevacizumab compared favorably with the dual immunotherapy combination of nivolumab (Opdivo) and ipilimumab (Yervoy), which also has been evaluated in advanced RCC, Pal noted.

“That [dual immunotherapy] regimen also demonstrated improved outcomes relative to sunitinib in patients with newly diagnosed metastatic kidney cancer, but nearly 60% of patients required steroids for management of side effects as compared with 16% in the study reported by Dr. Motzer.”

The study was supported by Roche/Genentech.

Motzer disclosed relevant relationships with Pfizer, Novartis, Eisai, Exelisix, Merck, GlaxoSmithKline, Bristol-Myers Squibb, and Roche Genentech.

2018-02-06T16:45:00-0500

Tagged with:

About author

Related Articles