Bevacizumab Does Not Improve Outcomes With Chemotherapy in Early NSCLC

Excerpt:

“The addition of bevacizumab to adjuvant chemotherapy failed to improve survival outcomes in patients with surgically resected early-stage non–small-cell lung cancer (NSCLC), according to a new randomized trial. The agent “does not have a role” in this setting, the investigators concluded.

” ‘In the setting of advanced-stage NSCLC, the first agent to improve survival when added to a platinum doublet was bevacizumab,’ wrote authors led by Heather A. Wakelee, MD, of the Stanford Cancer Institute at Stanford University in California. The researchers tested whether the VEGF-targeted agent would be similarly effective in the early-stage NSCLC adjuvant setting, where patients remain at high risk of relapse despite chemotherapy.”

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Linifanib With Chemotherapy Delays Disease Worsening in Advanced Non-Squamous NSCLC

The gist: People with advanced non-squamous non-small cell lung cancer (NSCLC) might do better if a drug called linifanib is added to chemo treatment with the drugs carboplatin and paclitaxel. In a clinical trial with volunteer patients, people who took all three drugs went for several weeks longer without their disease worsening than patients who took only carboplatin and paclitaxel.

“The addition of linifanib to a carboplatin and paclitaxel regimen offered significantly improved progression-free survival (PFS) over placebo in a randomized phase II trial of patients with advanced non-squamous non–small-cell lung cancer (NSCLC).

“Previous work has shown that adding inhibitors of VEGF to standard chemotherapy can improve survival outcomes in advanced NSCLC. Linifanib (Abbott Laboratories) is a tyrosine kinase inhibitor with activity against VEGF and PDGF receptors. “Single-agent activity of linifanib in phase I and II clinical studies in patients with advanced NSCLC encouraged further evaluation of linifanib as a component of therapy for these patients,” wrote study authors led by Suresh S. Ramalingam, MD, of Winship Cancer Institute of Emory University in Atlanta…

“ ‘Although additional studies of linifanib in NSCLC are not currently planned, further evaluation of linifanib in patients with the identified biomarker signature is warranted,’ the authors concluded. ‘These findings are also of potential significance for other antiangiogenic agents presently under development for NSCLC.’ ”


Lpath Reports Interim Data From Phase 2a Study for Anti-Cancer Drug, ASONEP

Editor’s note: Researchers are conducting a clinical trial with volunteer patients to test a new kidney cancer treatment called ASONEP. Specifically, the trial is testing the effectiveness of ASONEP for people with metastatic renal cell carcinoma (RCC) who were previously but unsuccessfully treated with at least one “VEGF inhibitor” drug (like Sutent, aka sunitinib) and no more than one “mTOR inhibitor” drug (like Afinitor, aka everolimus), with a maximum of three unsuccessful previous treatments overall. The clinical trial is ongoing, but interim results show that ASONEP is safe and hasn’t caused serious side effects. The researchers also said the drug appeared to show promise as a cancer-fighting treatment.

“Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported interim results in a Phase 2a single-arm, open-label trial where ASONEP™ is being investigated as a treatment for metastatic renal cell carcinoma (RCC) in patients that have failed at least one therapy involving a VEGF inhibitor (e.g., Sutent®/ sunitinib maleate) and no more than one mTOR inhibitor (e.g., Afinitor®/everolimus), with a maximum of three failed treatments in all. This patient population is considered “last line,” and the literature suggests cancer progression in this population within a one-to-two month time frame.

“Lpath has enrolled 26 patients in the study. ASONEP has a favorable safety profile thus far, with no serious adverse events (SAEs) deemed to be drug-related.

“The first 17 patients were initiated at a dose of 15 mg/kg. Of these “lower-dose” patients:  7 had progressive disease at or before the end of four months; 8 were progression-free at the four-month mark (with 1 of these patients deemed a partial responder per Response Evaluation Criteria in Solid Tumors (RECIST) criteria and with 3 of these patients experiencing reduced tumor volume, but not enough to be categorized as a RECIST-based partial responder); and 2 exited the study due to SAEs unrelated to the drug prior to the four-month mark (and are not considered evaluable). Notably, of the 8 patients that were stable or better as of month four, 2 are now in their fifteenth month on the study, 1 is in month thirteen, and 1 is in month ten. An additional patient was stable through month seven, but then missed six treatments during a vacation, and shortly thereafter progressed.”


Sunitinib or Everolimus First-Line for Kidney Cancer?

Editor’s note: Researchers conducted a clinical trial with volunteer patients to compare two drugs for kidney cancer: everolimus (aka Afinitor) and sunitinib (aka Sutent). The results showed that sunitinib is more effective as a first-line treatment for people diagnosed with metastatic renal cell carcinoma (mRCC). The standard treatment already widely prescribed to mRCC patients is sunitinib or a similar drug, followed by everolimus if the disease worsens. Oncologists wondered if everolimus could be a first-line therapy for mRCC, but it appears that the current standard is the better choice.

“Everolimus (Afinitor, Novartis) is not as effective as sunitinib (Sutent, Pfizer) in the first-line setting for patients with metastatic renal cell carcinoma, and it has a different toxicity profile, according to a phase 2 randomized direct comparator trial.

“The study, known as RECORD-3, was published online July 21 in the Journal of Clinical Oncology.

” ‘The hope was that everolimus would be better tolerated and as good as sunitinib in first-line treatment,’ said lead investigator Robert Motzer, MD, attending physician in the genitourinary oncology service at the Memorial Sloan Kettering Cancer Center and professor of medicine at Weill Medical College at Cornell University in New York City.

“However, ‘in first-line therapy, the efficacy of sunitinib appeared to be better than everolimus. It is clear that sunitinib remains the standard first-line therapy,’ he explained.

” ‘The current paradigm of sunitinib followed by everolimus at progression should be maintained. The experimental sequence of everolimus first followed by sunitinib second did not appear to be as effective,’ Dr. Motzer reported.”


Hypertension Related to New Cancer Therapies – A New Syndrome Emerges

“New cancer therapies, particularly agents that block vascular endothelial growth factor (VEGF) signaling, have improved the outlook for patients with some cancers and are now used as a first line therapy for some tumors. However, almost 100% of patients who take VEGF inhibitors (VEGFIs) develop high blood pressure, and a subset develops severe hypertension. The mechanisms underlying VEGF inhibitor-induced hypertension need to be better understood and there is a need for clear guidelines and improved management, say investigators in a review article published in the Canadian Journal of Cardiology.”


Hypertension Related to New Cancer Therapies – A New Syndrome Emerges

“New cancer therapies, particularly agents that block vascular endothelial growth factor (VEGF) signaling, have improved the outlook for patients with some cancers and are now used as a first line therapy for some tumors. However, almost 100% of patients who take VEGF inhibitors (VEGFIs) develop high blood pressure, and a subset develops severe hypertension. The mechanisms underlying VEGF inhibitor-induced hypertension need to be better understood and there is a need for clear guidelines and improved management, say investigators in a review article published in the Canadian Journal of Cardiology.”


Hypertension Related to New Cancer Therapies – A New Syndrome Emerges

“New cancer therapies, particularly agents that block vascular endothelial growth factor (VEGF) signaling, have improved the outlook for patients with some cancers and are now used as a first line therapy for some tumors. However, almost 100% of patients who take VEGF inhibitors (VEGFIs) develop high blood pressure, and a subset develops severe hypertension. The mechanisms underlying VEGF inhibitor-induced hypertension need to be better understood and there is a need for clear guidelines and improved management, say investigators in a review article published in the Canadian Journal of Cardiology.”


Marker May Predict Response to Ipilimumab in Advanced Melanoma

“Among patients with advanced melanoma, presence of higher levels of the protein vascular endothelial growth factor (VEGF) in blood was associated with poor response to treatment with the immunotherapy ipilimumab, according to a study published inCancer Immunology Research, a journal of the American Association for Cancer Research.

“The study suggests combining immunotherapy with VEGF inhibitors, also known as angiogenesis inhibitors, may be a potential option for these patients.”