Focus: Bristol-Myers Squibb’s wonder drug – Opdivo
pharmafile | April 20, 2016 | Feature | Research and Development, Sales and Marketing | BMS, growth, immuno-oncology, opdivo, sales
By Anjali Shukla
New data for Bristol-Myers Squibb’s (NYSE: BMY) Opdivo to treat head and neck cancer showed superior survival compared with current standard chemotherapies in late stage trials, the company said.
The trial was stopped early due to the survival benefit observed with Opdivo, BMS said following recommendations from an independent monitoring committee. Opdivo blocks a protein called Programmed Death receptor (PD-1) that is used by tumours to evade the body’s natural defences.
UK principal investigator Professor Kevin Harrington, says: “Nivolumab was not only more effective than chemotherapy for patients with head and neck cancer but also had fewer side-effects, and has the potential to significantly extend life and increase quality of life.”
If approved in the indication, the therapy is estimated to clock in annual sales of $1 billion for head and neck cancer.
Opdivo competes with Merck & Co’s (NYSE: MRK) Keytruda, which has received priority review for head and neck cancer from the US Food and Drug Administration (FDA).
Opdivo: The Wonder Drug
Bristol-Myers Squibb (BMS) pioneered the marketing of the new generation of immunotherapy drugs for cancer, medicines that aid the individuals’ immune system to fight cancer cells. Its Yervoy received approval in March 2011 while Opdivo, which is already proving to be a blockbuster drug, got regulatory nod in 2014. The two drugs have jointly helped BMS generate revenue of $4.29 billion last year, with Opdivo alone accounting for $475 million in sales in the fourth quarter of last year. Total annual sales for Opdivo stood at a staggering $942 million. The jump in revenue generation is extraordinary for the product that has been in the market only since mid-2014.
Yervoy and Opdivo also received FDA approval in 2015 for the immunotherapy combination treatment for a kind of metastatic melanoma.
Even though Opdivo arrived late to the party closely following Merck’s Keytruda, it has quickly captured the immuno-oncology drug market leaving the rival behind. The drug is forecast to bring in annual sales of $11.1 billion by 2020, making it the third biggest-selling drug in the world.
In addition, the slew of FDA approvals in different indications for Opdivo are a clear demonstration of its ability to garner positive results from trial studies and in turn rake in additional sales going forward. In 2015, Opdivo received seven FDA approvals across three tumour types. Given the optimism around the compound, there is clearly more to come as the company is engaged in conducting 50 trials for Opdivo in about 25 tumour types. Data from several of these trials is expected in 2016.
Immuno-oncology: Competition heats up
The field of medical trials has been abuzz with the potential of immuno-oncology products in treating various forms of cancer and the pharma companies are in the race to develop compounds in several indications. The immuno-oncology segment is forecast to be one of the higher revenue-generating therapy areas going forward as competition heats up. With immuno-oncology market estimated to hit $40 billion in annual sales, big pharma has been pouring resources to research and develop new molecules for the multiple segments of immuno-oncology.
Pharma companies are estimated to have spent up to $100 billion in 2015 to develop immunotherapy drugs with research and development expenditure expected to surge to $147 billion by 2018.
BMS’ Opdivo and Merck’s Keytruda are set to be the highest-selling immuno-oncology drugs, clocking in around $10 billion and $7 billion by 2024, respectively, according to Globaldata.
However, estimates firmly place Opdivo way ahead of Merck’s Keytruda, which was initially launched as treatment for melanoma in late 2014. In comparison, Roche’s Atezolizumab and AstraZeneca’s Durvalumab, which work slightly differently by targeting PD-L1, are yet to reach the market.
Going ahead early launches will also play a significant role in sealing the market shares of the pharma players. Further, the rapid success of the immunotherapy drugs in multiple clinical trials have boosted sales forecasts as physicians plug into the idea of aiding the immune system to fight cancer.
“Immuno-oncology products have demonstrated comparable respective efficacy and safety profiles, so their commercial success will largely rest on the speed with which they enter the market, their clinical and commercial positioning, target patient populations, and the marketing power of the relevant pharmaceutical company,” Dan Roberts, senior analyst at GlobalData says.
However, opportunities for late-to-market entrants will still remain, despite the market dominance of a small number of products.
“AstraZeneca is the company to look out for in regards to the development of novel combinations. Indeed, it has the most late-phase combination trials, predominantly investigating its internally-owned immuno-oncology combination product in a number of cancers,” Roberts, says.
Needless to say it will remain a highly competitive market for immunotherapies as BMS races ahead with Opdivo in tow adding one regulatory approval after another. Along with Brostol-Myers Squibb, the other big players developing immuno-oncology compounds include, AstraZeneca (LSE:AZN), Johnson & Johnson (NYSE: JNJ), MSD (FRA:MRK), Merck & Co (NYSE: MRK), Novartis (VTX: NOVN), Sanofi (EPA: SAN), and Pfizer (NYSE: PFE).
Combination therapy
With hectic research activity across all big pharma players to launch immune-oncology products, the markets are bound to see a flood of immunotherapy products in the coming years. However, the PD-1/ programmed death ligand-1 (PD-L1) inhibitors is expected to eventually hit a saturation point. Experts have also indicated that even though the drugs have been helpful in improving overall survival in some patients, they still only work in about 25% of patients, giving way for the therapies to be tried in combination formats.
In addition to studying the compound as a monotherapy, drugmakers have also started combination trials to test the efficacy and safety for the compounds. Pharma companies are also forging alliances and collaborating to test their compounds with other immunotherapy candidates.
Roche and Amgen are collaborating to evaluate the safety and efficacy of their combination therapy talimogene laherparepvec in triple-negative breast cancer and colorectal cancer with liver metastases.
The developers are also evaluating different combinations of immuno-oncology treatments, with either other immuno-oncology or non-immuno-oncology products.
BMS has also announced trial results for its combination study with Opdivo and Yervoy to treat a form of advanced skin cancer. The Phase II trials showed a two-year overall survival rate of 69% in patients with another form of advanced melanoma.
Going ahead, the approval and uptake of immuno-oncology products is set to flourish boosted by increased recognition of their long and durable tumour responses. Additionally, not only have these treatments demonstrated efficacy in multiple indications they also do not have the wide variety of side effects associated with traditional chemotherapy, sealing their position as a more desirable treatment option.
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