Bristol-Myers Squibb: The Next Generation
The leaders of Bristol-Myers Squibb are hoping that Opdivo and Eliquis will each generate multi-billion sales growth for years to come.
Bristol-Myers Squibb Co.
345 Park Avenue
New York, NY 10154
Phone: 212-546-4000
Website: bms.com
Best-Selling Products
| Product | 2015 Sales | 2014 Sales |
|---|---|---|
| Orencia |
$1,885 |
$1,652 |
| Eliquis | $1,860 | $774 |
| Sprycel | $1,620 | $1,493 |
| Hep C Franchise | $1,603 | $256 |
| Baraclude | $1,312 | $1,441 |
| Sustiva Franchise | $1,252 | $1,444 |
| Reyataz | $1,139 | $1,362 |
| Yervoy | $1,126 | $1,308 |
|
Opdivo |
$942 | $6 |
| Abilify |
$746 |
$2,020 |
| Erbitux |
$501 |
$723 |
All sales are in millions of dollars.
Financial Performance
| 2015 | 2014 | |
|---|---|---|
| Revenue | $16,560 | $15,879 |
| Net income | $1,631 | $2,029 |
| Diluted EPS | $0.93 | $1.20 |
| R&D expense |
$5,920 |
$4,534 |
| 1H16 | 1H15 | |
|---|---|---|
| Revenue | $9,262 | $8,204 |
| Net income |
$2,394 |
$1,089 |
| Diluted EPS | $1.41 | $0.63 |
| R&D expense | $2,402 | $2,872 |
In millions of dollars, except EPS
Immuno-oncology is no longer just a buzzword for Bristol-Myers Squibb. After several years of hype, the company’s golden child Opdivo is finally delivering the goods, with nearly a billion dollars in sales in its first full year on the market in 2015 and plenty more clearly to come. The drug has already been approved for indications in melanoma, non-small cell lung cancer, renal cell carcinoma, and Hodgkin lymphoma, with applications pending in several other potential indications and many more still in development. Aside from Opdivo, the cardiovascular drug Eliquis is looking like a winner as well; after crossing the billion-dollar mark with ease in 2015, its second full year on the market, Eliquis may hit $3 billion in sales this year. With these two impressive starts, BMS executives are clearly hoping that Opdivo and Eliquis will spend many years dueling at the top of the company’s sales charts. All this just in time, too, with longtime blockbuster Abilify losing its patent protection in April 2015.
“Going forward, we plan to continue seizing our unprecedented opportunity for growth, for transforming cancer care, and for helping even more people with our diverse portfolio of innovative medicines,” says Giovanni Caforio, M.D., CEO of Bristol-Myers Squibb. “Inspired by the stories of our patients, fueled by the passion of our employees and driven by a genuine sense of urgency – I don’t think anything can stop us.”
BMS’ top-line revenue in 2015 was $16.56 billion, an improvement of 4.3 percent compared with the previous year. The improvement was mostly due to Opdivo – almost $1 billion in sales in year one, and tracking towards $3 billion in year two; the company’s new hepatitis C franchise; and more than a billion dollars of additional revenue from Eliquis, partially offset by changes in foreign currency rates; expiration of U.S. and European Union rights to Abilify; and competitive pressures resulting from exclusivity losses and other factors for Baraclude, Reyataz, and Sustiva in certain markets. Net income for the year was down about 19.6 percent to $1.63 billion and earnings per share declined 27 cents to $0.93; according to company leaders, this was due to upfront payments for licensing and asset acquisitions of investigational compounds.
In the first half of 2016, top-line revenue rose 12.9 percent to $9.26 billion, with net income more than doubling from $1.09 billion to $2.39 billion and earnings per share up 78 cents to $1.41. BMS executives expect earnings per share for full-year 2016 to fall between $2.43 and $2.53.
Product Performance
The autoimmune product Orencia was tops on BMS’ charts in 2015, earning $1.89 billion in sales, an improvement of 14.1 percent. According to company executives, this was due to higher average net selling prices and increased demand in the United States, as well as increased demand for the subcutaneous formulation internationally. In the first half of 2016, Orencia sales rose another 24 percent to $1.07 billion. Orencia is indicated for adult patients with moderate to severe active rheumatoid arthritis and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.
In July, BMS announced the commercial launch of the Orencia ClickJect Autoinjector, a new self-administered autoinjector for adults with moderate to severe rheumatoid arthritis. The Orencia ClickJect delivers 125 milligrams of subcutaneous Orencia with push button operation and injection confirmation, which may reduce the possibility of user errors. The Orencia ClickJect has an ergonomic design and non-slip grip that may allow for control by dexterity-compromised patients. Orencia is now the only RA biologic that offers three administration options: IV infusion, prefilled syringe, and Autoinjector.
In September, the European Commission approved Orencia intravenous infusion and subcutaneous injection, in combination with methotrexate, for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with MTX. With this approval, Orencia became the first biologic therapy with an indication in the European Union specifically applicable to the treatment of MTX-naive RA patients with highly active and progressive disease. Studies of Orencia involving adult patients with high disease activity accompanied by poor prognostic factors for rapidly progressive disease provided the clinical trial evidence supporting the recommendation. This approval allows for the expanded marketing of Orencia in all 28 Member States of the EU.
Following close behind Orencia – and soon to overtake it – was the cardiovascular drug Eliquis, which generated sales of $1.86 billion for BMS in 2015, well more than double the $774 million of the previous year. According to company leaders, this jump was due to higher demand following the 2013 launches in most major markets for the reduction of the risk of stroke and systemic embolism for patients with NVAF and the treatment of VTE in 2014 in the United States and in 2015 in the EU. In the first half of 2016, sales of Eliquis nearly doubled again, from $792 million to $1.51 billion.
The leukemia product Sprycel had sales of $1.62 billion in 2015, an improvement of 8.5 percent over the previous year. Company executives credited this to higher demand both in the United States and internationally. In the first half of 2016, Sprycel sales were up another 10 percent to $858 million.
BMS’ hepatitis C franchise – including Daklinza and Sunvepra – generated an impressive $1.6 billion in sales in 2015, even though Daklinza was only launched in the United States in July 2015. Company executives expect revenue for the franchise to decline significantly in the second half of 2016 due to increased competition. In the first half of 2016, the hep C franchise earned $973 million in sales, an improvement of 31 percent.
In January, the European Commission approved Daklinza for the treatment of chronic hepatitis C in three new patient populations. The expanded label allows for the use of Daklinza in combination with sofosbuvir (with or without ribavirin, depending on the indication and HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1 (human immunodeficiency virus) coinfection, and post-liver transplant recurrence of HCV in all 28 Member States of the European Union. A similar label expansion was approved by FDA the following month.
Baraclude, indicated for the treatment of hepatitis B, generated $1.31 billion in sales for BMS in 2015, down 9 percent compared with the previous year. This came mostly due to loss of exclusivity in the United States, offset in part by higher demand internationally. In the first half of 2016, sales of Baraclude were $590 million, a decrease of 13.6 percent.
The Sustiva franchise of HIV products brought in $1.25 billion in sales in 2015, a decrease of 13.3 percent. According to company executives, this was due to increased competition as well as the ongoing impact of the drug’s loss of exclusivity in the EU in 2013. In the first half of 2016, Sustiva franchise sales were down another 10.4 percent to $544 million.
BMS’ other HIV blockbuster franchise, Reyataz, generated $1.14 billion in sales in 2015, down 16.4 percent compared to the previous year. This decrease, company leaders say, was due to increased competition both in the United States and internationally. In the first half of 2016, sales of the Reyataz franchise fell another 21.6 percent to $468 million.
The melanoma drug Yervoy earned $1.13 billion in sales for BMS in 2015, down 13.9 percent from the previous year. According to company executives, this was due to the introduction of other immuno-oncology products, including Opdivo. In the first half of 2016, Yervoy sales dropped another 18.8 percent to $504 million.
And then, of course, there is Opdivo. In 2015, its first full year on the market, BMS’ prize immuno-oncologic generated an impressive $942 million in sales, and that number has already been left far in the rearview, with $1.54 billion in sales during the first half of 2016.
Most of the Opdivo news lately, though, has not been about the drug’s impressive sales – it’s been about all the additional indications brewing in the pipeline. In April, the European Commission approved Opdivo monotherapy for an additional indication in advanced renal cell carcinoma after prior therapy in adults. Opdivo is the first PD-1 immune checkpoint inhibitor approved in Europe to demonstrate an overall survival benefit versus a standard of care in this patient population. That same month, BMS announced data from CheckMate-141, a Phase III open-label, randomized trial, evaluating Opdivo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab). In the trial, which evaluated overall survival as the primary endpoint, patients treated with Opdivo experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months compared to 5.1 months for investigator’s choice. The one-year survival rate for Opdivo was 36 percent compared to 16.6 percent for investigator’s choice.
That same month, FDA granted Breakthrough Therapy Designation to Opdivo for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy. And, the EC approved Opdivo monotherapy for locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy in adults. Opdivo is the only approved PD-1 inhibitor to demonstrate superior overall survival in two separate Phase III trials in previously treated metastatic NSCLC; one trial in squamous NSCLC (CheckMate-017) and the other in nonsquamous NSCLC (CheckMate-057), the basis of this approval.
In May, FDA approved Opdivo for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin. That same month, BMS announced two-year overall survival data from two pivotal Phase III studies evaluating Opdivo versus docetaxel in previously treated metastatic NSCLC. Opdivo continued to demonstrate improved overall survival, the primary endpoint for both studies, at the landmark two-year time point. In CheckMate-057, a trial in previously treated nonsquamous NSCLC, 29 percent of patients treated with Opdivo were alive at two years versus 16 percent of those treated with docetaxel. And, the European Commission approved Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults, representing the first approved combination of two immuno-oncology agents in the EU.
In June, BMS announced results from two trials evaluating the Opdivo + Yervoy combination regimen in advanced melanoma. In the pivotal Phase III trial, CheckMate-067, at a minimum follow-up of 18 months, the Opdivo + Yervoy combination demonstrated continued clinical benefit with a 58 percent reduction in the risk of disease progression versus Yervoy monotherapy, while Opdivo monotherapy demonstrated a 45 percent risk reduction versus Yervoy alone. Also in June, FDA granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.
In July, FDA accepted for priority review, the European Medicines Agency validated, and in Japan BMS’ partner Ono submitted applications for Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck. The three submissions were based on CheckMate-141, a pivotal Phase III open-label, randomized study, that evaluated the OS of Opdivo in patients with SCCHN after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel or cetuximab). This study was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee concluded the study met its primary endpoint of overall survival.
Practically the only bad news for Opdivo came in August, when BMS announced that CheckMate-026, a Phase III trial investigating the use of Opdivo as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer whose tumors expressed PD-L1 at ≥ 5 percent. In September though, the European Medicines Agency validated the company’s type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Aside from all those mentioned above and their variants, Opdivo also remains in development for additional indications in glioblastoma, hepatocellular carcinoma, gastric cancer, and esophageal cancer.
Acquisitions & Collaborations
In February, BMS and Dana-Farber Cancer Institute entered into a research collaboration agreement as part of the Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the United States. Dana-Farber Cancer Institute is the latest leading, academic-based cancer center to join the I-O RPM program, which is a multi-institutional initiative focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy.
“Dana-Farber Cancer Institute and Bristol-Myers Squibb have a shared commitment to patients and to continuing to advance the science in Immuno-Oncology research,” says Laura Bessen, M.D., head of U.S. Medical, Bristol-Myers Squibb. “We look forward to working with them as part of the I-O RPM program.”
As part of the I-O RPM program, Bristol-Myers Squibb and Dana-Farber Cancer Institute will conduct a range of early phase clinical studies and Bristol-Myers Squibb will support the training of young investigators who contribute to the I-O RPM program at Dana- Farber.
Also in February, BMS completed the sale of its HIV R&D portfolio to ViiV Healthcare, including a number of programs at different stages of discovery, preclinical, and clinical development. Bristol-Myers Squibb received from ViiV Healthcare a payment of $350 million in connection with the closing. Under the terms of the transaction agreements, Bristol-Myers Squibb will also receive from ViiV Healthcare potential development and regulatory milestone payments of up to $518 million for the clinical assets, and up to $587 million for the discovery and pre-clinical programs. If and when products are approved and commercialized, ViiV Healthcare will pay tiered royalties. Additionally, ViiV Healthcare will pay sales-based milestone payments of up to $750 million for each of the clinical assets and up to $700 million for each of the discovery and pre-clinical programs.
The agreements with ViiV Healthcare do not impact Bristol-Myers Squibb’s marketed HIV medicines, including Reyataz, Evotaz, Sustiva, and Atripla. Bristol-Myers Squibb remains committed to the commercialization of these products and to those patients who rely on these medicines.
Also in February, BMS and Pfizer entered into a collaboration agreement with Portola Pharmaceuticals Inc. to develop and commercialize the investigational agent andexanet alfa in Japan. Andexanet alfa, which is in Phase III clinical development in the United States and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis. Under the terms of the agreement, Portola will receive an upfront payment of $15 million, potential regulatory milestones of $20 million, and sales-based milestones of $70 million as well as compensation based on andexanet alfa net sales. BMS and Pfizer will co-fund with Portola the development and commercialization of andexanet alfa in Japan. Portola will retain rights to andexanet alfa outside of Japan and remain responsible for the manufacturing supply.
“We are committed to reducing the risk of stroke in nonvalvular atrial fibrillation patients and treating deep vein thrombosis and pulmonary embolism,” says Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “Bristol-Myers Squibb and Pfizer’s agreement with Portola is an important step forward toward the goal of delivering the first reversal agent for Factor Xa inhibitors, including Eliquis, to patients in Japan. The ability to reverse the anticoagulation effect of Eliquis and other Factor Xa inhibitors may be helpful for some patients who experience a major bleeding event or require emergency surgery while on Eliquis or another Factor Xa inhibitor.”
In March, BMS signed a definitive agreement to acquire all of the outstanding capital stock of Padlock, a private, Cambridge, Mass.-based biotechnology company dedicated to creating new medicines to treat destructive autoimmune diseases. The acquisition gave BMS full rights to Padlock’s Protein/Peptidyl Arginine Deiminase (PAD) inhibitor discovery program focused on the development of potentially transformational treatment approaches for patients with rheumatoid arthritis. Padlock’s PAD discovery program may have additional utility in treating systemic lupus erythematosus and other autoimmune diseases. The transaction included upfront and near term contingent milestone payments of up to $225 million and additional contingent consideration of up to $375 million upon the achievement by Bristol-Myers Squibb of certain development and regulatory events.
PADs are a family of enzymes that produce autoantigens which play an active role in the development and progression of RA and other autoimmune diseases. Inhibiting PADs offers the potential to prevent progression of autoimmune diseases early in their evolution. In identifiable high risk patients with pre- and early-RA, PAD inhibition could lead to a paradigm shift in treatment by preventing disease development and resulting joint destruction. PAD4 inhibition in combination with current standard of care therapies may increase and maintain the durable remission rates in RA patients with rapidly progressive disease.
“Targeting PAD enzymes has the potential to be one of the most innovative mechanisms for treating autoimmunity which both strengthens and accelerates our immunoscience pipeline,” says Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. “By pursuing a treatment approach which may address disease progression earlier, we hope to transform the lives of patients with RA and other autoimmune diseases.”
In June, BMS and The University of Texas MD Anderson Cancer Center announced a new clinical research collaboration to evaluate innovative strategies for the potential use of Opdivo and Yervoy to treat early- and advanced-stage lung cancer patients. The collaboration will help support multiple Phase I and II clinical trials testing Opdivo as monotherapy, in combination with Yervoy, or in regimens with other agents, radiation, or surgery in a range of clinical settings. These studies will also incorporate extensive translational work including exploration of novel biomarkers to better differentiate responders from non-responders in lung cancer as well as preclinical studies of next generation immunotherapeutic agents that may be used to expand the benefits to larger numbers of patients.
The collaboration, executives say, will take advantage of MD Anderson’s existing immunotherapy platform, which helps to link immunologic data with the genomic and proteomic platforms across a range of cancer types, and broaden the scientific understanding of I-O via preclinical and clinical studies in lung cancer. Data generated will assist BMS in optimizing I-O combinations for future clinical trials while also enhancing mechanistic understanding of immune system function in mounting of anti-tumor responses.
“Strategic collaborations with academia have been central to helping Bristol-Myers Squibb develop and deliver new immuno-oncology treatment options to patients,” says Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb. “This collaboration will leverage the considerable experience of MD Anderson to accelerate and expand our scientific and clinical understanding of how the immune system and other treatments might work together to fight cancer.”
Also in June, BMS and PsiOxus Therapeutics Ltd. entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Opdivo to treat a range of tumor types in late-stage cancer patients. Enadenotucirev is designed to have immune stimulating effects while Opdivo is designed to alleviate immune suppression. The clinical collaboration will support Phase I studies to determine whether combining these two agents can significantly improve the proportion of patients achieving objective tumor responses, the extent of tumor shrinkage, and/or the durability of responses.
“This collaboration continues to expand our clinical development of Opdivo and explores how oncolytic viruses may provide a complementary mechanism to address tumors that are resistant to I-O therapy,” Dr. Viallet says. “We are excited to partner with PsiOxus to evaluate the combination of Opdivo and enadenotucirev to accelerate our understanding of its potential as a new therapeutic option for cancer patients.”
PsiOxus’ enadenotucirev is an oncolytic group B adenovirus therapeutic that is given intravenously and is currently in Phase I clinical studies for multiple solid tumor types. Enadenotucirev is a virus that selectively replicates in tumor cells but not in normal cells. Such viruses promote anti-tumor responses through a dual mechanism of action that is dependent on selective tumor cell killing and the induction of systemic anti-tumor immunity. Preclinical data demonstrate that this approach is potentially applicable to a broad range of epithelially derived solid tumors, many of which have compelling unmet needs even when treated with checkpoint inhibitors.
Bristol-Myers Squibb will make a one-time upfront payment of $10 million to PsiOxus, and the parties will share development costs. PsiOxus will be responsible for conducting the Phase I study with patient recruitment expected to start in the third quarter of 2016. Additionally, the companies will work exclusively with each other on anti-PD-1/PD-L1 antagonist antibody and enadenotucirev combination regimens, and Bristol-Myers Squibb will have a time-limited right of exclusive negotiation for commercial rights to enadenotucirev.
During July, BMS and AbbVie announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie’s investigational biomarker specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) in combination with Opdivo and Opdivo + Yervoy regimen as a treatment for relapsed extensive-stage small cell lung cancer. The Phase I/II clinical program is exploring the potential of combining BMS’ immuno-oncology agents, which are designed to alleviate immune suppression, in conjunction with AbbVie’s investigational antibody drug conjugate, Rova-T, to drive improved and sustained efficacy and tolerability above the current standard of care. Rova-T is a novel antibody drug conjugate that targets and eliminates tumor initiating cells and other bulk tumor cells. This collaboration will determine if the targeted cell killing and antigen release caused by Rova-T may further enhance the effect of immunotherapy.
“We are excited to explore the potential benefits of combining Bristol-Myers Squibb’s immunotherapies with a targeted approach like Rova-T in small cell lung cancer where the need for new therapies is particularly acute for this aggressive form of lung cancer,” Dr. Viallet says. “As the science around cancer research continues to rapidly evolve, we are building on our leadership in Immuno-Oncology with numerous collaborations that may help advance new therapies for cancers in need of better options.”
Small cell lung cancer is a difficult-to-treat form of cancer that accounts for about 15 percent of all lung cancers. The five-year survival rate for extensive stage SCLC is less than 5 percent and treatment options are limited for the more than 234,000 people diagnosed annually.
Also in July, BMS acquired all of the outstanding capital stock of Cormorant, a private, Stockholm, Sweden-based pharmaceutical company focused on the development of therapies for cancer and rare diseases. The acquisition gives Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program and the lead candidate HuMax-IL8, a Phase I/II monoclonal antibody targeted against interleukin-8 (IL-8) that represents a potentially complementary immuno-oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules. The transaction includes upfront and near term contingent milestone payments of up to $95 million and additional contingent consideration of up to $425 million upon the achievement by Bristol-Myers Squibb of certain development and regulatory milestones.
IL-8 is a protein expressed by many solid tumors within the tumor microenvironment that suppresses the immune system and increases the ability of tumors to metastasize. By targeting IL-8, HuMax-IL8 offers the potential to enhance immune response and increase the efficacy of existing cancer medicines through combination therapy. The rights to HuMax-IL8 were acquired by Cormorant from Genmab A/S in 2012 under an exclusive license agreement.
“We believe combination therapy will be foundational to delivering the potential for long term survival for patients, and the opportunity to develop the HuMax-IL8 antibody program together with our broad Immuno-Oncology pipeline enables us to accelerate the next wave of potentially transformational immunotherapies,” Dr. Cuss says.
Also in July, BMS announced a new clinical research collaboration with Janssen Biotech Inc. to evaluate Opdivo and Janssen’s Live Attenuated Double–Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer. JNJ-64041757 is designed to induce the local recruitment and activation of innate and adaptive effector cells and expansion of mesothelin-specific T cells. The Phase II clinical trial will evaluate the tolerability and clinical activity of the combination of these agents in NSCLC patients.
“We are excited to collaborate with Janssen as we explore how the emerging science of antigen-presentation therapeutics, in combination with Opdivo, can potentially provide a new treatment approach for patients with lung cancer,” Dr. Viallet says.
JNJ-64041757 (previously referred to as ADU-214) is an antigen-presentation therapeutic, based on Live Attenuated Double-Deleted (LADD) Listeria monocytogenes strains engineered to induce an immune response against NSCLC tumors. It is currently in Phase I clinical development for lung cancer. Opdivo is indicated for the treatment of patients with NSCLC with progression on or after platinum-based chemotherapy.
Recent Approvals/In The Pipeline
In May, the European Commission approved Empliciti (elotuzumab) for treating multiple myeloma as combination therapy with Celgene Corp.’s Revlimid and dexamethasone in patients who have received at least one prior therapy. Empliciti is now the first and only immunostimulatory antibody approved for multiple myeloma in the European Union.
The approval was based on data from the randomized, open-label, Phase III ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone (Rd) alone. The co-primary endpoints of this study, progression-free survival as assessed by hazard ratio and overall response rate, were achieved, with extended follow-up data showing a 53 percent relative improvement in PFS rate at three years (23 percent versus 15 percent). Additionally, a prespecified interim analysis for overall survival found a positive trend favoring the Empliciti combination versus Rd alone, though at the time of the interim analysis, the OS endpoint had not reached the predetermined threshold for statistical significance. Patients will continue to be followed for survival, and the final analysis is pending.
“At Bristol-Myers Squibb, we are committed to delivering pioneering medicines with the goal of revolutionizing the way cancer is treated for patients who inspire our work each and every day,” says Emmanuel Blin, senior VP and head of Commercialization, Policy and Operations, Bristol-Myers Squibb. “With the approval of Empliciti in the EU, we are proud to extend our Immuno-Oncology science to multiple myeloma patients in Europe who have received at least one prior therapy.”
