Breaking News
April 26, 2018 - UNC-Chapel Hill receives new award to help improve health of North Carolinians
April 26, 2018 - Study finds no evidence of chronic wasting disease transmissibility in macaques
April 26, 2018 - Study highlights impact of early detection on skin cancer survival
April 26, 2018 - Scientists discover culprit in reducing effectiveness of insulin
April 26, 2018 - Exploiting rabies virus machinery to usher Parkinson’s disease drug directly to the brain
April 26, 2018 - ‘Rapid autopsy’ programs seek clues to cancer within hours of death
April 26, 2018 - Personalised prescriptions according to your genetics
April 26, 2018 - ECDC analysis highlights measles vaccination gaps in teenagers and young adults
April 26, 2018 - Study assesses link between cognitive function levels and crash risk among older drivers
April 26, 2018 - Researchers uncover how obesity leads to cancer initiation
April 26, 2018 - Consuming large quantities of sugar during pregnancy can affect child’s cognition, shows study
April 26, 2018 - Researchers create new tool to measure patient uncertainty for predicting hospital readmissions
April 26, 2018 - FDA Alert: Lamictal (lamotrigine): Drug Safety Communication
April 26, 2018 - Massive single-cell survey of kidney cell types reveals new paths to disease
April 26, 2018 - Cognitive behavioral therapy can help children with autism manage emotional challenges
April 26, 2018 - CU Anschutz Medical Campus receives NIH grant to speed up discovery of new treatments
April 26, 2018 - Researchers discover significant distortions in leading genetics study method
April 26, 2018 - New combination therapy could improve survival in children with high-risk neuroblastoma
April 26, 2018 - Scientists clarify casual role of oxidative stress in metabolically abnormal and healthy obesities
April 26, 2018 - Home-based exercise program found ineffective for patients with peripheral artery disease
April 26, 2018 - Surgeries performed by older surgeons have lower patient mortality rates, study reveals
April 26, 2018 - New UCLA study could elucidate certain causes of infertility and miscarriage
April 26, 2018 - Choroidal Thickness Changes in Patients With Untreated DM
April 26, 2018 - Medical chemists discover peptic ulcer treatment metallodrug effective in ‘taming’ superbugs
April 26, 2018 - UB researchers build 3D-printed, drug-filled dentures to fight against infections
April 26, 2018 - Researchers find role of iron storage gene in slowing down prostate cancer growth
April 26, 2018 - Study suggests link between regular mid-day naps and neurocognitive function in teens
April 26, 2018 - Researchers gain ground-breaking insights into how inflammatory diseases work
April 26, 2018 - Injured U.S. Vet Receives World’s First Penis/Scrotum Transplant
April 26, 2018 - Researchers find existing drug effective at preventing onset of type 1 diabetes
April 26, 2018 - MGH researchers identify risk factors for drug overdose in youth with substance use disorders
April 26, 2018 - Researchers develop new vaccine to help people overcome bath salts abuse
April 26, 2018 - Genetic signature predicts diabetes diagnosis
April 26, 2018 - Study shows link between restless legs syndrome symptoms and brain structure
April 26, 2018 - MU researchers use new techniques to fight against diabetic retinopathy
April 26, 2018 - AAE’s new practice statements aim at improving patient care
April 26, 2018 - Expression of long non-coding RNAs can result in high levels of specific proteins involved in cancer
April 26, 2018 - FDA re-examining safety of new drug approved for Parkinson’s disease psychosis
April 26, 2018 - Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy
April 26, 2018 - Bacteria boost antifungal drug resistance in severe childhood tooth decay
April 26, 2018 - New study affirms bedtime habits of Americans
April 26, 2018 - Hospital patients are more interested in tracking their health data, research shows
April 26, 2018 - Study shows gene variations associated with malaria risk
April 26, 2018 - Inhealthcare teams up with MSKassist to combat problems related to obesity and aging
April 26, 2018 - Caffeine during pregnancy – babies 66 percent more likely to become overweight
April 26, 2018 - FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease
April 26, 2018 - Pricey dental implants often best but insurance rarely pays
April 26, 2018 - Advion’s Peak Express software now available with the expression compact mass spectrometer
April 25, 2018 - Researchers find link between pneumonia in older people and PPI prescriptions
April 25, 2018 - Alcohol damages microbiome in the mouth
April 25, 2018 - Regular soaking in hot tub improves health outlook in obese women with PCOS
April 25, 2018 - FDA Alert: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers
April 25, 2018 - Sunshine could hold clues on the timing for a severe form of heart attack, study says
April 25, 2018 - Sartorius Stedim Biotech launches mini bioreactor vessel for ambr 250 high throughput system
April 25, 2018 - Biofeedback-assisted relaxation may help children during medical procedures
April 25, 2018 - Key signaling protein in Huntington’s disease found to have deleterious effects on heart function, shows study
April 25, 2018 - Celecoxib Lowers Opioid Use Post Head & Neck Cancer Surgery
April 25, 2018 - New ‘brain health index’ can predict how well patients will do after stroke
April 25, 2018 - Positive interventions in sepsis management raise key questions about E. coli reduction targets
April 25, 2018 - Scientists identify new DNA structure within living human cells
April 25, 2018 - E. coli’s toxin-antitoxin system inhibits bacterial growth
April 25, 2018 - Researchers uncover reason why exercise may be beneficial for the heart
April 25, 2018 - Researcher presents case study of asymptomatic patient with severe mitral regurgitation
April 25, 2018 - Use ‘Proper Form’ When Practicing Yoga
April 25, 2018 - Study reports possible novel method for stopping untreatable pediatric brain cancers
April 25, 2018 - Visually guided walking paves way for better treatment for mobility impairments
April 25, 2018 - Researchers identify novel pathway in development of AML with poor prognosis
April 25, 2018 - Cardiovascular disease may only be a matter of time for people with healthy obesity
April 25, 2018 - Girls with type 2 diabetes have high frequency of menstrual irregularities
April 25, 2018 - Study explains why intense exercise curbs appetite
April 25, 2018 - Experimental drug for rheumatoid arthritis prevents side effect of stem cell transplants
April 25, 2018 - Why are Antibiotics Overprescribed for Meningitis Treatment?
April 25, 2018 - Consuming protein supplements with meals, rather than between meals, may promote weight control
April 25, 2018 - Seeing prostate cancer in a new light
April 25, 2018 - Jacobs Medical Center recognized with Baby Friendly Designation for efforts in mother-baby bonding
April 25, 2018 - Gene related to high fatality could be used as biomarker in patients with P. aeruginosa infection
April 25, 2018 - Study shows patients in major prostate cancer study are more likely to die than real-world patients
April 25, 2018 - HBP researchers develop new tool to examine role of genes in disease-relevant brain regions
April 25, 2018 - Trio’s pioneering silicone ostomy product wins prestigious Queen’s Award for Enterprise
April 25, 2018 - Study highlights potential of stem cells derived from adults in regenerative medicine
AbbVie Announces Results from Phase 2 Study Evaluating Rovalpituzumab Tesirine (Rova-T) for Third-Line Treatment of Patients with DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer

AbbVie Announces Results from Phase 2 Study Evaluating Rovalpituzumab Tesirine (Rova-T) for Third-Line Treatment of Patients with DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer

image_pdfDownload PDFimage_print

NORTH CHICAGO, Ill., March 22, 2018 /PRNewswire/ — AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, today announced that after consulting with the U.S. Food and Drug Administration (FDA), it will not seek accelerated approval for Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC) based on magnitude of effect across multiple parameters in this single-arm study.

“We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers,” said Mike Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. “Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing Phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer.”

In the study, the most common treatment-emergent adverse events were fatigue (38 percent), photosensitivity reaction (36 percent), pleural effusion (32 percent), edema peripheral (31 percent), decreased appetite (30 percent), nausea (26 percent), dyspnea (25 percent), thrombocytopenia (25 percent), constipation (22 percent), vomiting (17 percent), anemia (17 percent), hypoalbuminemia (16 percent), and cough (16 percent). Grade three and higher severe toxicities ≥ 5 percent were thrombocytopenia (11 percent), photosensitivity reaction (7 percent) and pleural effusion (5 percent).

About the Phase 2 TRINITY Study

TRINITY is a multicenter, open-label, single-arm, Phase 2 study of Rova-T in DLL3-expressing small cell lung cancer (SCLC) patients with relapsed/refractory (R/R) disease after receiving at least two previous regimens, including at least one platinum-based regimen. The primary objective was to investigate the efficacy of Rova-T as third-line and later treatment for R/R DLL3-expressing SCLC. Secondary objectives included assessment of safety and tolerability, pharmacokinetics, RECIST-assessed progression-free survival, duration of response and clinical benefit rate.

About Rovalpituzumab Tesirine (Rova-T)

Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3)[1], which is expressed in more than 80 percent of small cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.[2] Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells. Rova-T is under investigation as a third-line treatment in SCLC.[2] The expression of DLL3 suggests Rova-T may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme and some prostate, pancreatic and colorectal cancers.[2]

Rova-T is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

[1] Saunders L. R. et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo. Sci. Transl. Med. 2015;7(302): 1-13.

[2] ClinicalTrials.gov (2016). Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY). Accessed March 21, 2018. https://clinicaltrials.gov/ct2/show/NCT02674568?term=SC16LD6.5&rank=2.

SOURCE AbbVie

Posted: March 2018

Tagged with:

About author

Related Articles