publication date: Dec. 4, 2015

FDA Approves Opdivo Injection for Renal Cell Carcinoma 


FDA approved Opdivo (nivolumab) injection for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

In the CheckMate -025 trial, patients treated with Opdivo achieved a median OS of 25 months (95% CI: 21.7-not estimable) versus 19.6 months (95% CI: 17.6-23.1) for everolimus, a current standard of care (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]), based on a prespecified interim analysis.

In the study, the safety profile was consistent with prior Opdivo studies.

“This is the fifth approval for Opdivo across three distinct tumor types. This latest approval reflects our commitment to delivering on our promise to provide cancer patients with a potential for long-term survival,” said Francis Cuss, executive vice president and chief scientific officer at Bristol-Myers Squibb, Opdivo’s sponsor. “We believe our pioneering approach to Immuno-Oncology is driving change in how cancer may be treated.”

The U.S. approval was based on data from CheckMate -025, an open-label, randomized phase III study which demonstrated a median OS benefit of 25 months (95% CI: 21.7-NE) compared with 19.6 months (95% CI: 17.6-23.1) for everolimus (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]).

FDA previously granted Breakthrough Therapy Designation to Opdivo for advanced RCC patients treated with prior anti-angiogenic therapy, also based on positive results from the CheckMate -025 study.

“This approval of Opdivo represents a major milestone for the kidney cancer community,” said William P. Bro, chief executive officer and patient coordinator, Kidney Cancer Association. “We thank Bristol-Myers Squibb and the FDA for working swiftly to bring this important new treatment option and potential for extended survival to patients.”


The European Commission granted marketing authorization for Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Kyprolis, sponsored by Amgen, is the first irreversible proteasome inhibitor approved in the European Union for use in combination treatment of patients with relapsed multiple myeloma.

“In clinical studies, approximately one out of three patients achieved a complete response or better on the Kyprolis in combination with lenalidomide and dexamethasone arm, which is three times more frequent than in the lenalidomide and dexamethasone arm,” said Prof. Meletios Dimopoulos of the National and Kapodistrian University of Athens School of Medicine. “In addition, the regimen provided patients with more than two years without disease progression. These results are significant for patients with relapsed multiple myeloma, who are faced with worse outcomes each time they experience a relapse.”

The EC approved Kyprolis based on data from the phase III ASPIRE trial. The study showed that patients treated with Kyprolis in combination with lenalidomide and dexamethasone had increased median time to progressive disease or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone.

The median progression-free survival was 26.3 months in the KRd arm compared to 17.6 months in the Rd arm (HR: 0.69; 95% CI: 0.57 to 0.83; p=0.0001).

The most common adverse events in the Kyprolis arm included pneumonia, myocardial infarction and upper respiratory tract infection. Discontinuation of treatment due to AEs occurred in 15 percent of patients in the KRd arm versus 18 percent of patients in the Rd arm.

Kyprolis received an accelerated assessment from the European Medicines Agency, and orphan drug designation in 2008.


The European Medicines Agency accepted a marketing authorization application for review of anamorelin HCI, a novel, orally active selective ghrelin receptor agonist under development for the treatment of anorexia, cachexia, or unintended weight loss in non-small cell lung cancer patients. Anamorelin is being developed by Helsinn.

Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, lean body mass, appetite and metabolism. Anamorelin is an investigational agent that has not yet been approved by any regulatory authority.


Roche and Upsher-Smith Laboratories Inc., through its wholly-owned U.K. subsidiary Proximagen Ltd., announced a worldwide agreement for the further development of a novel, oral small molecule inhibitor of Vascular Adhesion Protein 1, a cell-adhesion molecule that may be effective in the treatment of inflammatory disease. The VAP-1 inhibitor is currently in phase II clinical development.

Under the terms of the agreement, Roche is granted a worldwide exclusive license to develop and commercialize the compound. In a novel collaboration model, Proximagen and Roche will conduct additional phase II studies to further define the therapeutic potential of the VAP-1 inhibitor. Based on these data, Roche will assume responsibility for late stage development and worldwide commercialization.

Proximagen will receive an upfront payment, along with downstream development, regulatory and sales milestones. In addition, Proximagen will also receive tiered royalties on net sales of a potential future product containing the molecule.


MD Anderson Cancer Center and Boehringer Ingelheim announced a collaboration focused on developing innovative medicines for pancreatic ductal adenocarcinoma.

The collaboration will focus on identifying and developing therapeutic concepts in novel target areas as well as identification of biomarkers that can accurately identify patients who would respond to potential new therapies.

“This partnership is a perfect match because it combines MD Anderson’s outstanding capabilities in preclinical concept validation and clinical testing with Boehringer Ingelheim’s strength in developing innovative medicines,” said Clive Wood, senior corporate vice president of Discovery Research at Boehringer Ingelheim.


Morphotek Inc., a subsidiary of Eisai Inc., entered into an agreement with the Targeted Alpha Therapy Group at the University of Gothenburg in Sweden to collaborate on the research and development of farletuzumab as an alpha therapy vector being studied for radioimmunotherapy in ovarian cancer.

Farletuzumab is an investigational humanized monoclonal antibody that binds to folate receptor alpha, a protein which is highly expressed in ovarian carcinoma but largely absent from normal tissue.

In radioimmunotherapy, mAbs are attached to radioisotopes that may potentially deliver highly cytotoxic radiation in a targeted and more direct way to relevant cancer cells. The use of alpha emitters, in contrast to beta emitters, may potentially allow for the killing of only targeted cells binding with the vector due to the short alpha particle track. This collaboration will initially investigate the use of farletuzumab as an alpha therapy vector in preclinical laboratory studies, followed by the overall objective, which is to investigate in clinical trials the safety and efficacy of alpha-radiolabeled farletuzumab in women who enter remission upon completion of first-line treatment.

Farletuzumab is currently being tested in a clinical study in first-relapsed, platinum-sensitive ovarian cancer patients with low CA125 levels. The double-blind, randomized-controlled study is designed to prospectively evaluate the clinical effects observed in the previously conducted phase III trial in the pre-specified subset of patients treated with farletuzumab exhibiting low CA125 levels.

The TAT Group’s research activities will be coordinated by various departments at the Sahlgrenska Academy, University of Gothenburg, under the direction of Associate Professor Per Albertsson, an oncologist at Sahlgrenska University Hospital.


Caris Life Sciences and Syapse will collaborate to collect and combine molecular and genomic information with clinical treatment and outcomes data across the Caris Centers of Excellence for Precision Medicine Network.

Integration of Caris Molecular Intelligence, Caris’ panomic, comprehensive tumor profiling service, with the Syapse Precision Medicine Platform , will provide a powerful real-time, point-of-care, clinical decision support system to enable more informed treatment decisions for each individual patient. Participating COE Network sites can use the integrated decision support system, and may use Syapse to further support their complete precision medicine workflows.

Caris Molecular Intelligence uses multiple technology platforms, including a proprietary 592-gene Next-Generation Sequencing panel with full gene coverage to assess point mutations, indels, and copy number variations, alongside RNAseq, for select gene fusions, in addition to Immunohistochemistry, in situ hybridization, and other platforms.

“We expect to profile 50,000 to 100,000 cancer patients annually across the COE Network. This is the largest oncology focused effort to combine comprehensive genomic and molecular profiling information with clinical outcomes data,” said David Halbert, chairman and CEO of Caris Life Sciences.

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