The Pharmafocus ASCO round-up
pharmafile | June 7, 2016 | Feature | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | ASCO, Pharmafocus
As the curtain falls on another annual ASCO (American Society of Clinical Oncology) congress, catch up on all the biggest news with the Pharmafocus round-up.
Late-stage trials
A few familiar faces made an appearance among the late-stage trial data announced at ASCO, with multiple myeloma drugs well represented.
Janssen’s Darzalex has performed well in previous trials which has led to various regulatory approvals, and recently made its first commercial sale in Europe. This latest data presented at ASCO reinforces its efficacy, in combination with bortezomib and dexamethasone, in patients with multiple myeloma. Like certain other promising oncology drugs, Janssen seems keen to press on with trialling Darzalex (daratumumab) in various ways. In this trial, a 61% in progression-free survival was observed in patients taking the treatment combo.
Lead study investigator, Antonio Palumbo, said: “These compelling Phase III results demonstrate that a regimen built on daratumumab deepens clinical responses and help to underscore its potential for multiple myeloma patients who have been previously treated.”
Another multiple myeloma drug with positive trial data at ASCO was Amgen’s Kyprolis (carfilzomib). Already approved in Europe and the US in combination with lenalidomide and dexamethasone, this drug combination greatly increased progression-free survival, with a median of 24.1 months compared to 12.5 months in patients treated with lenalidomide and dexamethasone, alone.
Amgen’s executive VP of R&D, Sean E. Harper, commented: “This analysis showed that in early relapsing multiple myeloma patients, the addition of Kyprolis to lenalidomide and dexamethasone resulted in patients living longer without their disease progressing, a significant milestone for patients living with this difficult-to-treat disease.”
Other big late-stage news came from Mylan, who presented data on their proposed biosimilar for Roche’s breast cancer drug, Herceptin (trastuzumab). A consistent blockbuster drug for Roche, the Phase III HERITAGE trial demonstrated the efficacy, safety and immunogenicity of Mylan’s biosimilar of Herceptin, MYL-1401O. Lead study author, Dr Hope S. Rugo, indicated: “The ratio of overall response and difference in overall response fell within a narrow, pre-defined equivalence margin suggesting equal efficacy of both products.”
Opdivo
It is clear that Bristol-Myers Squibb has very high hopes for potential “wonder drug”, Opdivo (nivolumab). The anti-PD-1 monoclonal antibody has already been approved in multiple cancer indications, such as advanced lung and kidney cancer and metastatic melanoma. Not content with just these indications, BMS has been trialling Opdivo in many further indications both as a monotherapy and as a combination therapy.
At ASCO, early-stage data was presented in advanced non-small cell lung cancer, metastatic colorectal cancer and advanced bladder cancer. David Feltquate, development lead in oncology life cycle management at BMS, said: “We are encouraged by the preliminary results from our ongoing efforts to evaluate the full potential of this combination regimen across a range of malignancies.”
Data on Opdivo is set to become a regular fixture at ASCO over the coming years, with Bristol-Myers Squibb eyeing up multi-billion sales if their wonder drug continues to prove efficacious in more and more cancer indications.
Mixed results
AbbVie had its first opportunity to present data on Rova-T (rovalpituzumab tesrine), the compound it has recently acquired in a $5.8 billion deal with Stemcentryx, at the ASCO but it seems the markets, at least, weren’t impressed with the data on show.
Shares fell over 5% upon the release of the data which showed that 11 out of 60 (18%) lung cancer patients receiving Rova-T experienced tumour shrinkage with a median overall survival rate of 5.8 months. While AbbVie were feeling positive about these results, investors may not have been. With BMS’s Opdivo/Yervoy combination performing well in similar indications, AbbVie and Rova-T certainly have competition in the market.
It certainly wasn’t a good ASCO for personalised medicine drugmakers, Immunomedics. The company was prevented from presenting mid-stage data for its breast cancer drug, sacituzumab, as company management had already presented material planned for the ASCO at a conference in April. Unfortunately for Immunomedics, it looks like they had quite strong data to present. The markets thought so too with the stock price rising steadily in the run-up to the congress.
Falling foul of the ASCO rules, however, has been a big blow to the company with the stock price falling and an opportunity missed. President and CEO at Immunomedics, Cynthia L. Sullivan, commented: “Both we and our many investigators involved are disappointed that our excellent therapeutic results, achieving an interim median survival of about 14 months, may not be presented at this meeting. These results are very encouraging for triple-negative breast cancer patients with metastatic disease who failed multiple therapies.”
To read more of our coverage at this year’s ASCO, please click here.
Sean Murray
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