Bristol-Myers Squibb 2018: The future is now
With two potential $6 billion brands now at the top of the company’s portfolio, Bristol-Myers Squibb is officially through the lean times.
Bristol-Myers Squibb Co.
345 Park Avenue
New York, NY 10154
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All sales are in millions of dollars.
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All figures are in millions of dollars, except EPS.
Bristol-Myers Squibb’s product portfolio has come a long way in a short time. Five years ago the leading product by revenue was the soon-to-go-generic antipsychotic Abilify with $2.29 billion in sales as none of BMS’ other brands reached $2 billion. But in 2017, the company’s two leading standard-bearers, Opdivo and Eliquis, each nearly reached $5 billion in sales; both are on track to hit $6 billion this year and seem likely to anchor BMS’ top line for years to come.
Opdivo, already approved for the treatment of at least nine tumor types, remains in clinical trials for a bewilderingly large number of additional indications, while Eliquis stands solidly second behind Xarelto in the novel oral anticoagulant space. For BMS executives who survived the lean times of 2013, this future looks to be beyond even their fondest hopes.
“Much of the work we did in 2017 has positioned us well for continued growth,” says Giovanni Caforio, M.D., chairman and CEO of Bristol-Myers Squibb. “Our financials are solid. Our portfolio and pipeline are increasingly robust and diversified. And our work to evolve our operating model has transformed our company in ways that are helping us to work smarter, faster and better.”
Bristol-Myers Squibb’s top-line revenue was $20.78 billion in 2017, an improvement of 6.9 percent over the previous year. Net income fell from $4.51 billion to $975 million, and EPS from $2.65 to 61 cents, but this was impacted by several one-time items. The items includes a $2.91 billion charge related to the recent U.S. tax reform and $1.13 billion in license and asset acquisition charges. After adjusting for these and other one-time items, company leaders estimated that net income growth was about 4.6 percent.
During the first half of 2018, Bristol-Myers Squibb’s top line was $10.9 billion, an improvement of 8.1 percent, though net income fell by 23.3 percent to $1.88 billion and EPS was down 37 cents to $1.13. Company executives are projecting full-year EPS for 2018 to fall between $2.68 and $2.78.
The immuno-oncologic Opdivo just missed reaching the $5 billion revenue mark for BMS in 2017 with sales of $4.95 billion, an improvement of 31.1 percent over the previous year. According to company leaders, this was due to higher demand as a result of launches of additional indications and approvals in new countries. In the first half of 2018 sales of Opdivo rose another 35.1 percent to $3.14 billion. The product has been approved for cancer indications across bladder, blood, colon, head and neck, kidney, liver, lung, melanoma, and stomach.
But perhaps even more impressive than Opdivo’s sales so far this year have been the product’s vast clinical development record. In March, FDA approved a supplemental Biologics License Application updating the Opdivo dosing schedule to include 480 milligrams infused every four weeks (Q4W) for a majority of approved indications. This approval provides health care professionals with the flexibility to customize patient care with the option of using the newly approved Q4W (480 milligrams) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 milligrams, now available in a new 240 milligram vial. Opdivo also was approved for a shorter 30-minute infusion across all approved indications.
In April, FDA approved Opdivo 3 mg/kg plus Yervoy 1 mg/kg as the first immuno-oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). In the Phase III CheckMate -214 clinical trial, the Opdivo + Yervoy combination demonstrated a significant and unprecedented increase in overall survival in this patient population compared to a current standard of care, sunitinib. An OS benefit was observed regardless of PD-L1 expression level. Opdivo + Yervoy also delivered durable responses, with a higher objective response rate (ORR) compared to sunitinib.
Additionally in April, BMS announced initial results from the pivotal Phase III study, CheckMate -227, evaluating the Opdivo 3 mg/kg plus low-dose Yervoy 1 mg/kg combination in first-line advanced non-small cell lung cancer patients with high tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). In the study, the combination demonstrated a superior benefit for the co-primary endpoint of progression-free survival versus chemotherapy. The PFS benefit was observed regardless of PD-L1 expression levels and in both squamous and non-squamous tumor histology. Additionally, based on an early descriptive analysis, encouraging overall survival was observed with the combination versus chemotherapy in patients with high TMB ≥10 mut/Mb.
Also in April, BMS announced two-year overall survival data from CheckMate -141, a Phase III open-label, randomized trial evaluating Opdivo compared with the investigator’s choice chemo (cetuximab, docetaxel, or methotrexate) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after failure on platinum-based therapy. Patients treated with Opdivo experienced a 32 percent reduction in the risk of death after a minimum two years of follow-up, with a median OS of 7.7 months compared with 5.1 months for standard chemotherapy. The two-year survival rate for Opdivo was 16.9 percent versus 6.0 percent for standard chemotherapy.
During June, FDA accepted BMS’ supplemental Biologics License Application for Opdivo plus low-dose Yervoy for the treatment of first-line advanced non-small cell lung cancer in patients with tumor mutational burden ≥10 mutations per megabase (mut/Mb). The target FDA action date is February 20, 2019. The application was based on results from Part 1 of CheckMate -227, the first global Phase III study to evaluate an immuno-oncology/I-O regimen versus chemotherapy in a population of first-line NSCLC patients with TMB ≥10 mut/Mb, across squamous and non-squamous tumor histologies and the PD-L1 expression spectrum.
In other June news, the China National Drug Administration (CNDA) approved Opdivo for the treatment of locally advanced or metastatic non-small cell lung cancer after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations. This approval made Opdivo China’s first PD-1 inhibitor and the only immuno-oncology agent to demonstrate a survival benefit compared with chemotherapy, based on data from the pivotal Phase III CheckMate -078 trial, in which 90 percent of the patients enrolled were Chinese.
In the CheckMate -078 clinical study, Opdivo reduced the risk of death by 32 percent versus chemotherapy – the primary endpoint – in patients with previously treated NSCLC. The clinical trial was stopped early during November 2017 because the independent data monitoring committee concluded that Opdivo demonstrated superior overall survival compared with chemotherapy.
Also in June, BMS announced patient-reported outcomes data from the Phase III CheckMate -214 trial in intermediate- and poor-risk patients with advanced renal cell carcinoma treated with Opdivo plus low-dose (1mg/kg) Yervoy versus sunitinib over a two-year follow-up period. Patients in the study treated with Opdivo plus low-dose Yervoy reported significant benefits in disease-related symptoms and improvements to their cancer-related quality of life and well-being. These benefits occurred early during Opdivo plus low-dose (1mg/kg) Yervoy combination therapy and were largely maintained throughout the treatment period and through Opdivo maintenance therapy.
Relative to the current standard of care, patients in the Opdivo plus low-dose Yervoy arm reported fewer kidney cancer symptoms as measured by the NCCN Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19). This benefit was significant at all but one post-baseline time point through two years of follow-up. Time to deterioration (TTD) in FKSI-19 total score was also significantly delayed with Opdivo plus low-dose Yervoy versus sunitinib.
Also in June, FDA lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase III study evaluating the addition of Opdivo to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The decision followed consultation with FDA and agreement on amendments to the study protocol.
Three studies evaluating Opdivo-based combos in relapsed or refractory multiple myeloma were placed on partial clinical hold in September 2017 as an FDA precaution following risks identified in trials for another anti–PD-1 agent, pembrolizumab, in patients with multiple myeloma. CheckMate -602 is the last of the three studies to have its partial clinical hold lifted following a similar FDA action announced in December 2017, when U.S. regulators lifted partial holds on CA209-039 (CheckMate -039) and CA204-142.
In July, the European Commission approved Opdivo for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This indication is for BRAF mutant and wild-type melanoma patients. With this decision, Opdivo became the first PD-1 therapy to receive an EC approval in the adjuvant setting and the drug gained an eighth indication across six distinct tumor types in the European Union.
The EU approval was based on results from the ongoing Phase III randomized double-blind CheckMate -238 trial, which studied Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma according to the AJCC Cancer Staging Manual 7th edition. The 18-month recurrence-free survival (RFS) was 66.4 percent for Opdivo versus 52.7 percent for Yervoy. Meanwhile, Opdivo reduced the risk of disease recurrence by 35 percent versus Yervoy. Additionally, adjuvant treatment with Opdivo was well tolerated, with 14.4 percent of patients experiencing treatment-related grade 3/4 adverse events and 9.7 percent discontinuing due to toxicity. Opdivo was approved for a similar indication by FDA in December 2017.
During August, FDA regulators approved Opdivo as the only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Marketing clearance for this indication was granted under accelerated approval based on overall response rate and duration of response. The approval was based on data from the SCLC cohort of the ongoing Phase I/II CheckMate -032 study evaluating Opdivo in patients who experienced disease progression after platinum-based chemotherapy. Of 109 patients receiving Opdivo after platinum-based chemotherapy and at least one other prior line of therapy, 12 percent responded to treatment based on assessment by a Blinded Independent Central Review, regardless of PD-L1 expression.
Twelve patients had a partial response (11 percent), and one patient had a complete response (0.9 percent). Among these responders, the median DOR was 17.9 months. Opdivo was discontinued in 10 percent of patients, and one dose was withheld in 25 percent of patients for an adverse reaction. Serious adverse reactions occurred in 45 percent of patients.
Also in July, FDA approved Opdivo plus low-dose Yervoy for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Approval for this indication was granted under accelerated approval based on overall response rate and duration of response.
The new indication was based on data from the ongoing Phase II CheckMate -142 study evaluating the Opdivo + Yervoy combination in patients with MSI-H or dMMR mCRC previously treated with a fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy. In this trial, among the 82 patients who received prior treatment with a fluoropyrimidine, oxaliplatin and irinotecan, 46 percent responded to treatment with Opdivo + Yervoy as assessed by Independent Radiographic Review Committee (IRRC).
Among all enrolled patients, 49 percent responded to treatment with Opdivo + Yervoy; 4.2 percent experienced a complete response, while 45 percent experienced a partial response. Among these 58 responders, the median DOR was not reached (range: 1.9-23.2+ months); 83 percent of those patients had responses of six months or longer, and 19 percent had responses of 12 months or longer. In the combination cohort, 51 of 58 responders were ongoing at the time of database lock; 78 percent of these ongoing responders had not reached 12 months of follow-up from the date of onset of response.
For all the noise Opdivo has been making, the anticoagulant Eliquis has actually been growing sales even more rapidly and looks to pass the drug’s stablemate in total sales this year. Sales of Eliquis were $4.87 billion in 2017, an improvement of 45.7 percent over the previous year. According to company leaders, this performance was due to higher demand resulting from increased commercial acceptance of novel oral anticoagulants and market-share gains.
In the first half of 2018, sales of Eliquis rose another 38.6 percent to $3.16 billion, even edging past Opdivo for the same time period. Eliquis is targeted at stroke prevention in adult patients with non-valvular atrial fibrillation and the prevention and treatment of VTE disorders.
During March, BMS and Pfizer presented findings from a real-world data analysis titled, “Comparison of Effectiveness, Safety, and the Net Clinical Outcome between Different Direct Oral Anticoagulants in 162,707 Non-Valvular Atrial Fibrillation Patients Treated in US Clinical Practice.” This was the largest RWD analysis reporting outcomes among different direct oral anticoagulants (DOACs), including Eliquis, rivaroxaban and dabigatran, to date. In this analysis, apixaban use was associated with significantly lower rates of both stroke/systemic embolism (S/SE) and major bleeding (MB) when compared to rivaroxaban; and significantly lower rates of both S/SE and MB when compared to dabigatran.
Placing third in BMS’ portfolio in 2017, though without the spectacular growth of the top two, was the autoimmune drug Orencia. Sales of Orencia rose 9.4 percent for the year, to $2.48 billion. According to company leaders, this was due to higher average net selling prices and demand. In the first half of 2018, Orencia sales were up another 10 percent to $1.3 billion. Orencia is a fusion protein indicated for adult patients with moderate to severe active RA and PsA. The drug is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.
Next up on the BMS sales ladder is Sprycel. The company’s second most successful oncology brand brought in $2.01 billion in sales in 2017, an improvement of 9.9 percent. Company leaders credited this result to higher demand and average net selling prices. First-half 2018 sales of Sprycel edged up by 0.4 percent to $973 million.
Sprycel is an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec.
In July, the European Commission expanded the indication for Sprycel to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP), and to include a powder for oral suspension formulation. The approval makes Sprycel the first-ever tyrosine kinase inhibitor to be approved in a powder formulation for administration in pediatric patients and patients who cannot swallow tablets. Marketing clearance was based on data from CA180-226 (NCT00777036), the largest prospective trial evaluating the safety and efficacy of Sprycel in pediatric patients newly diagnosed with CP-CML, and in those resistant to or intolerant of imatinib.
During September, FDA accepted BMS’ supplemental Biologics License Application for Sprycel in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Ph+ acute lymphoblastic leukemia (ALL). FDA’s action date is December 29, 2018.
“Sprycel was first established as an important treatment option for appropriate pediatric patients last year, when it was approved for the treatment of children with Ph+ chronic myeloid leukemia,” says Jeffrey Jackson, Ph.D., development lead, hematology, Bristol-Myers Squibb. “This latest milestone in Ph+ ALL reinforces our commitment to researching the potential of Sprycel in different types of pediatric leukemia and to providing this vulnerable population with access to potential new therapies.”
The application was based on data from CA180-372 (NCT01460160), an ongoing Phase II trial evaluating the addition of Sprycel to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
The oncology product Yervoy generated $1.24 billion in sales for BMS in 2017, up 18.1 percent over the previous year. Company leaders say this was due to higher demand, in particular thanks to approvals of Opdivo + Yervoy combinations. In the first half of 2018, Yervoy sales actually fell by 13.5 percent to $564 million; according to published reports this was due to competition from its own stablemate Opdivo as well as Merck’s Keytruda. Yervoy is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma.
In January, the European Commission expanded the indication of Yervoy to include treatment of advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older. The EC approval marks Bristol-Myers Squibb’s first pediatric indication for an immuno-oncology medicine in the European Union.
Yervoy has been evaluated in pediatric and adolescent patient populations across two clinical trials: a dose-finding study in 33 patients aged 2 to 21 years with relapsed or refractory solid tumors; and an open-label, single-arm trial in 12 adolescents (ages ranging from 12 to 16 years) with previously treated or untreated, unresectable Stage III or IV malignant melanoma. FDA approved Yervoy to treat pediatric patients 12 years and older with unresectable or metastatic melanoma in July 2017.
Acquisitions and collaborations
BMS and Nektar Therapeutics in February announced the companies had executed a global strategic development and commercialization collaboration for Nektar’s lead immuno-oncology program, NKTR-214. Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with Bristol-Myers Squibb’s Opdivo and Opdivo plus Yervoy in more than 20 indications across 9 tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties. NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase PD-1 expression on those immune cells.
Bristol-Myers Squibb and Nektar have agreed to a joint clinical development plan to evaluate NKTR-214 with Opdivo and Opdivo plus Yervoy in registration-enabling clinical trials in more than 20 indications in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder, and triple negative breast cancer. Pivotal studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.
Under the terms of the agreement, Bristol-Myers Squibb will make an upfront cash payment of $1 billion and an equity investment of $850 million (8,284,600 shares of Nektar’s common stock at $102.60 per share). Bristol-Myers Squibb has agreed to certain lock-up, standstill, and voting provisions on its share ownership for a period of five years subject to certain specified exceptions.
Nektar is also eligible to receive an additional $1.78 billion in milestones, of which $1.43 billion are development and regulatory milestones and the remainder are sales milestones. Nektar will book revenue for worldwide sales of NKTR-214 and the companies will split global profits for NKTR-214 with Nektar receiving 65 percent and Bristol-Myers Squibb 35 percent. Bristol-Myers Squibb will retain 100 percent of product revenue for the company’s own medicines. The parties also will share development costs relative to their ownership interest of medicines included in the studies. For trials in the joint clinical development plan that include NKTR-214 with Opdivo only, the companies will share development costs with 67.5 percent allocated to Bristol-Myers Squibb and 32.5 percent allocated to Nektar. For trials in the joint clinical development plan that include NKTR-214 with Opdivo and Yervoy, the parties will share development costs with 78 percent allocated to Bristol-Myers Squibb and 22 percent allocated to Nektar.
Bristol-Myers Squibb and Nektar have agreed for a specified period of time to not commence development with overlapping mechanisms of action in the same indications as those included in the joint clinical development plan. The parties are otherwise free to develop NKTR-214 with their own pipeline assets and/or any other third-party compounds. Each company has agreed to initiate registration-enabling studies in the joint clinical development plan within 14 months of the effective date of the agreement, subject to allowable delays.
Both parties will jointly commercialize NKTR-214 on a global basis. Bristol-Myers Squibb will lead global commercialization activities for NKTR-214 combinations with Bristol-Myers Squibb medicines and Nektar will co-commercialize such combinations in the United States, major EU markets, and Japan. Nektar will lead global commercialization activities for NKTR-214 combinations with either Nektar medicines and/or other third-party medicines.
Nektar and Bristol-Myers Squibb entered into a clinical collaboration in September of 2016 to evaluate the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care. The Phase I/II PIVOT clinical study is ongoing in over 350 patients with melanoma, kidney, non-small cell lung cancer, bladder, and triple-negative breast cancers.
BMS announced in February that the Yale Cancer Center had joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance translational immuno-oncology science. Formed in 2012 by Bristol-Myers Squibb, the II-ON was one of the first networks to bring academia and industry together to further the scientific understanding of I-O, and has since expanded from 10 to 16 sites across North America, Europe, Japan, and Australia. Today, the partners collaborate to generate innovative I-O science, launch biology-driven studies and apply cutting-edge technologies with the goal of translating research findings into clinical trials and, ultimately, supporting efforts to improve survival outcomes across tumor types.
In April, BMS announced a worldwide collaboration with Janssen Pharmaceuticals on a Factor XIa (FXIa) inhibitor program that includes the development and commercialization of Bristol-Myers Squibb’s Factor XIa inhibitor BMS-986177. The investigational anticoagulant compound is being studied for prevention and treatment of major thrombotic conditions. The companies are expected to advance BMS-986177 into Phase II clinical trials in the second half of 2018 for the study of secondary stroke prevention.
Thrombotic disorders include cardiovascular conditions such as coronary artery disease, stroke and peripheral artery disease. BMS-986177 is an inhibitor of Factor XIa, and is being explored for the drug compound’s potential to improve upon the standard of care by reducing the risk of vascular events – without increasing the risk of bleeding – in patients with thrombotic disorders. Janssen will pay Bristol-Myers Squibb an upfront sum along with potential development and regulatory milestone payments. The companies will share development costs and commercial profits and losses. Additional terms of the agreement were not disclosed.
Also in April, BMS and Illumina announced a collaboration that will utilize Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb’s oncology portfolio. The companies plan to develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure potentially predictive genomic biomarkers, including Tumor Mutation Burden. Illumina’s TruSight Oncology 500 assay is being developed to detect most of the known biomarkers for oncology therapeutics, including TMB and Microsatellite Instability for immunotherapies.
In other April news, BMS and the Harvard Fibrosis Network of the Harvard Stem Cell Institute announced a research collaboration to discover and develop potential new therapies for fibrotic diseases, including fibrosis of the liver and heart. The Harvard Fibrosis Network brings together researchers across the schools and affiliated hospitals of Harvard University.
Fibrotic diseases impact many organs or tissues in the body, and are characterized by injury and chronic inflammation that lead to excess collagen deposition and scar formation in the affected organ or tissue. The scarring response compromises function and ultimately leads to organ failure. Treatments for fibrotic diseases are limited, and there is a significant unmet need for new options.
Under the terms of the agreement, leading academic investigators of hepatic and cardiac fibrosis from the Harvard Fibrosis Network will collaborate closely with leading scientists from Bristol-Myers Squibb on four projects over three years. Specific research projects will focus on applied fibrosis biology, identification of noninvasive biomarkers, and novel targets for potential anti-fibrotic therapies, in the areas of hepatic and cardiac fibrosis.
In May, BMS and Flatiron Health, a provider of oncology-specific electronic health record software and the curation of regulatory-grade real-world data for cancer research and real-world evidence (RWE) generation, expanded their relationship with a three-year collaboration agreement. Bristol-Myers Squibb will use Flatiron’s real-world data to accelerate research and development efforts, as well as improve the company’s ability to generate additional evidence on the use of its cancer medicines outside of clinical trials. With the expanded collaboration, the two companies intend to form a joint Scientific Advisory Board to advance the use of RWE for regulatory decision making.
Bristol-Myers Squibb will use Flatiron data to generate RWE across a substantial range of tumors and will collaborate, along with other stakeholders, on the development and validation of real-world endpoints within Flatiron’s longitudinal datasets. Additionally, the partnership includes broadened access to Flatiron and Foundation Medicine’s jointly established Clinico-Genomic Database.
In July, BMS and Tsinghua University entered into a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers. The collaboration, leaders say, brings together Bristol-Myers Squibb and Tsinghua University’s respective scientific expertise and capabilities with a focus on validating new targets and generating early drug candidates for clinical development.
Under the collaboration, The Innovation Center for Immune Therapy of Tsinghua University will conduct research on projects and Bristol-Myers Squibb will have an option to exclusively license therapeutic agents discovered by Tsinghua University. The collaboration is an expansion of an existing relationship between Bristol-Myers Squibb and Tsinghua University that began in 2012, which focused on autoimmune target discovery, structural biology research as well as the science of mapping the 3D protein structure of biological molecular targets.
In the pipeline
FDA accepted BMS’ supplemental biologics license application for Empliciti in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. FDA granted the application priority review with an action date of Dec. 27, 2018. The application is based on data from ELOQUENT-3, a randomized Phase II study evaluating the addition of Empliciti to pomalidomide and low-dose dexamethasone in patients with RRMM.
“This file acceptance is an important step in BMS’ ongoing efforts to advance treatment options for patients with relapsed/refractory multiple myeloma,” Dr. Jackson says. “Given the need for new, effective treatment options in this patient population, we look forward to working with the FDA with the hope of bringing this combination to patients with RRMM whose disease progressed on previous therapies as quickly as possible.”