Bristol-Myers Squibb 2019: More of everything
Bristol-Myers Squibb’s top two products just keep growing, and now the company may be adding a $10 billion brand via the planned acquisition of Celgene.
Bristol-Myers Squibb Co.
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|Product||2018 Sales||2017 Sales|
All sales are in millions of dollars.
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All figures are in millions of dollars, except EPS.
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Bristol-Myers Squibb had two nearly-$5 billion brands at the top of its portfolio the end of 2017 – not bad for any pharma company. But now it looks like the company will soon have two $7 billion brands, plus another that is on track to pass $10 billion in sales this year.
How? The two former almost-$5 billion brands, Opdivo and Eliquis, just keep growing, with both looking to easily pass $7 billion this year. And the oncologic Revlimid, with sales of $9.69 billion in 2018, may be on the way into BMS’ portfolio due to a hoped-for acquisition of Celgene announced this past January. Not bad for a company that did not even have a $2 billion product in the drug portfolio as recently as 2015.
“I am proud of our results in 2018, which were based on superior commercial performance for our prioritized brands and important scientific advances that continue to diversify our R&D pipeline,” said Giovanni Caforio, M.D., chairman and CEO, Bristol-Myers Squibb, at the end of the year. “We are beginning 2019 with good momentum in our current business, with Opdivo and Eliquis continuing as strong and growing franchises. Our planned acquisition of Celgene will position us to create a leading biopharma company, with best-in-class franchises, significant near-term launch opportunities and a deep and broad pipeline, creating an even stronger foundation for long-term sustainable growth.”
BMS’ top-line revenue in 2018 was $22.56 billion, an improvement of 8.6 percent compared with the previous year. Net earnings attributable to the company came in at $4.92 billion, nearly five times as much as in 2017, and earnings per share rose by $2.40 to $3.01. The 2017 numbers, though, included some unusual items – in particular a $2.91 billion charge related to U.S. tax reform. So better comparators might be earnings before income tax, which rose 16.3 percent to $5.97 billion, and the company’s non-GAAP EPS estimate, which rose from $3.01 in 2017 to $3.98 in 2018. In the first half of 2019, top-line revenue rose another 11.9 percent to $12.19 billion, while net earnings attributable to the company was up by more than two-thirds to $3.14 billion and EPS rose 79 cents to $1.92. Company leaders are expecting full-year 2019 EPS to fall in the $3.73 to $3.83 range.
In January, BMS and Celgene announced that they had entered into a definitive merger agreement under which Bristol-Myers Squibb would acquire Celgene in a cash and stock transaction with an equity value of about $74 billion. Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb shares and $50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones.
According to company executives, the transaction is expected to create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease, and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company’s strategic approach.
Based on the closing price of Bristol-Myers Squibb stock of $52.43 on Jan. 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing was valued at $102.43 per Celgene share and one CVR. When completed, Bristol-Myers Squibb shareholders are expected to own about 69 percent of the company, and Celgene shareholders are expected to own about 31 percent.
“Together with Celgene, we are creating an innovative biopharma leader, with leading franchises and a deep and broad pipeline that will drive sustainable growth and deliver new options for patients across a range of serious diseases,” Dr. Caforio said in the announcement. “As a combined entity, we will enhance our leadership positions across our portfolio, including in cancer and immunology and inflammation. We will also benefit from an expanded early- and late-stage pipeline that includes six expected near-term product launches. Together, our pipeline holds significant promise for patients, allowing us to accelerate new options through a broader range of cutting-edge technologies and discovery platforms.”
In June, BMS announced the future leadership team of the combined company effective upon completion of the pending merger with Celgene.
According to BMS executives, the company is evolving key aspects of its R&D and Commercialization structure to drive the continued growth of a successful marketed portfolio, maximize the six near-term launch opportunities, and deliver the value of the combined pipeline, all guided by its continued mission of serving patients with serious disease. The business, leaders say, will be supported by a lean infrastructure to enable efficiency and agility.
“I’m looking forward to working with this Leadership Team as we combine the strengths of Bristol-Myers Squibb and Celgene to enhance the value of our marketed portfolio, deliver six significant new product launches and realize the full potential of our deep and broad pipeline,” Dr. Caforio says. “We are building on a strong track record of best-in-class commercial execution, industry-leading science and a culture of collaboration and innovation. Together, we will create the leading biopharma company, one that will be known for pursuing the best science to create highly innovative medicines that bring meaningful benefits to patients and value to shareholders.”
In July, the European Commission granted unconditional approval of Bristol-Myers Squibb’s pending acquisition of Celgene.
In August, Celgene entered into an agreement with Amgen under which Amgen would acquire the global rights to Otezla for $13.4 billion in cash. Bristol-Myers Squibb had previously announced the decision to divest Otezla in connection with the ongoing regulatory approval process for the company’s pending merger with Celgene. The closing of the acquisition covered by the agreement with Amgen is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission in connection with their pending merger, the closing of the pending merger, and the satisfaction of other customary closing conditions.
Other acquisitions and partnerships
In July, BMS, Bayer and Ono Pharmaceutical Co. entered into a clinical collaboration agreement to evaluate the combination of Bayer’s kinase inhibitor Stivarga and Bristol-Myers Squibb’s/Ono’s Opdivo in patients with micro-satellite stable metastatic colorectal cancer, the most common form of mCRC.
Stivarga (regorafenib) as monotherapy has demonstrated an overall survival benefit versus placebo in the pivotal Phase III CORRECT study and has shown activity irrespective of micro-satellite status in a retrospective analysis from this study, though with limited responses observed. Despite progress in the treatment of CRC, including the advance of effective immuno-oncology treatments for certain subsets of CRC, about 95 percent of mCRC patients have MSS tumors, for which I-O monotherapy treatment approaches have shown limited activity. Thus, the need for additional treatment options including combination approaches remains high. Encouraging early data have been seen with the combination of Stivarga and Opdivo. In a Phase Ib investigator sponsored trial from Japan called REGONIVO (NCT03406871, EPOC1603), the combination of Stivarga and Opdivo has shown promising preliminary efficacy results.
Also in July, BMS completed the previously announced divestment of its consumer health business, UPSA, to Taisho Pharmaceutical Co., the largest over-the-counter drug company in Japan. The divestiture was part of Bristol-Myers Squibb’s strategy to simplify and to realign its business portfolio to address changes in its business and the future requirements of its evolving pipeline. UPSA is focused on delivering important consumer medicines in France, across Europe, and in additional countries that are outside of the Bristol-Myers Squibb core focus.
BMS’ immuno-oncologic Opdivo just keeps rolling up sales and new indications for the company. The product topped BMS’ charts again with $6.74 billion in sales in 2018, an improvement of 36.1 percent over the previous year. During the course of the year Opdivo earned five major approvals – two in Japan and one each in the United States, Europe, and China. The Opdivo plus Yervoy combination also earned two new indications in the United States and two more in Japan. According to company leaders, the brand’s revenue growth in 2018 was primarily due to FDA approvals for the treatment of adjuvant melanoma, liver cancer, and the Opdivo plus Yervoy combination for kidney cancer as well as additional indications and launches internationally, partially offset by a decline in the lung cancer indication. Growth has slowed a bit in the new year, but was still impressive, with sales up another 15.5 percent to $3.62 billion in the first half of 2019.
In January 2019, the European Commission approved the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg (“low-dose”) for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma. This decision represents the first approval of an Immuno-Oncology combination therapy for patients with this type of cancer in the European Union.
The approval was based on results from the Phase III CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed that the combination of Opdivo plus low-dose Yervoy demonstrated a significant increase in overall survival, with a 37 percent decreased risk of death in intermediate- and poor-risk patients compared to a current standard of care, sunitinib. The OS benefit was observed regardless of PD-L1 expression level. Median OS in patients treated with Opdivo plus low-dose Yervoy was not yet reached, compared to 25.9 months for patients treated with sunitinib.
Opdivo plus low-dose Yervoy also demonstrated a higher objective response rate of 41.6 percent versus 26.5 percent for sunitinib and a complete response rate of 9.4 percent for the Opdivo plus low-dose Yervoy cohort versus 1.2 percent for the sunitinib arm. Among patients who responded, median duration of response in patients treated with Opdivo plus low-dose Yervoy was not yet reached compared to 18.2 months for sunitinib. The combination of Opdivo plus low-dose Yervoy was also associated with fewer overall Grade 3 or 4 adverse events compared to sunitinib (65 percent versus 76 percent).
In February, BMS announced data evaluating Opdivo in combination with Yervoy in patients with metastatic castration-resistant prostate cancer. Results from an interim analysis of the Phase II CheckMate -650 trial showed that among 32 asymptomatic or minimally symptomatic patients whose disease had progressed after second-generation hormone therapy and who had not received chemotherapy (cohort 1), with a median follow-up of 11.9 months, the objective response rate was 25 percent. Additionally, among 30 patients whose disease progressed after taxane-based chemotherapy (cohort 2), with a median follow-up of 13.5 months, the ORR was 10 percent. Across both cohorts, higher response rates were seen in certain patient sub-groups, including patients with high (above median) tumor mutational burden and patients with homologous recombination deficiency.
Also in February, BMS announced new results from the Phase III CheckMate -214 study, showing that therapy with Opdivo plus low-dose Yervoy continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma. With a minimum follow-up of 30 months, intermediate- and poor-risk patients randomized to Opdivo plus low-dose Yervoy continued to show a significant overall survival benefit compared to those randomized to sunitinib. Additionally, at 30 months, the objective response rate per investigator for intermediate- and poor-risk patients with Opdivo plus low-dose Yervoy improved compared to the previous analysis at a minimum of 17.5 months. The 30-month OS rate for the intermediate- and poor-risk population was 60 percent for patients treated with Opdivo plus low-dose Yervoy versus 47 percent for patients treated with sunitinib. Opdivo plus low-dose Yervoy was associated with a 42 percent ORR versus 29 percent with sunitinib. More than half (52 percent) of the intermediate- and poor-risk patients who responded to Opdivo plus low-dose Yervoy had a response lasting at least 18 months versus 28 percent of the patients who responded to sunitinib. Also, the CR rate was 11 percent with Opdivo plus low-dose Yervoy versus 1 percent with sunitinib.
In April, BMS announced results from pooled analyses of survival data from four studies (CheckMate -017, -057, -063 and -003) in patients with previously treated advanced non-small cell lung cancer who were treated with Opdivo. In the pooled analysis of the four studies, 14 percent of all Opdivo-treated patients were alive at four years. Notably, in patients with PD-L1 ≥1% and <1%, four-year overall survival rates were 19 percent and 11 percent, respectively.
In the pooled analysis of the two Phase III trials, CheckMate -017 and -057, the four-year OS rate for Opdivo-treated patients was 14 percent compared to 5 percent for docetaxel-treated patients. Additionally, exploratory landmark analysis of OS found that of patients who had a complete or partial response at six months, 58 percent of those treated with Opdivo were alive four years later versus 12 percent of patients treated with docetaxel. Of patients who had stable disease at six months, 19 percent of those treated with Opdivo were alive four years later versus 2 percent of patients treated with docetaxel.
In May, BMS announced the Phase III CheckMate -498 trial evaluating Opdivo plus radiation versus temozolomide plus radiation in patients with newly diagnosed O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma multiforme did not meet its primary endpoint of overall survival at final analysis.
In June, BMS announced topline results from CheckMate -459, a randomized Phase III study evaluating Opdivo versus sorafenib as a first-line treatment in patients with unresectable hepatocellular carcinoma. The trial did not achieve statistical significance for its primary endpoint of overall survival per the pre-specified analysis. While CheckMate -459 did not reach its pre-specified primary endpoint, the results showed a clear trend towards improvement in OS for patients treated with Opdivo compared to sorafenib, a current standard of care.
Also in June, BMS announced updated results from studies evaluating Opdivo and Yervoy, alone or in combination, in patients with advanced or metastatic melanoma. A five-year analysis of the Phase I CA209-004 study, the longest follow-up for the Opdivo plus Yervoy combination in patients with previously treated or untreated advanced melanoma to date, showed that with a median follow-up of 43.1 months (range: 0.9-76.7) in all patients, at four years or longer, overall survival rates were stable at 57 percent. The three-year OS rate following discontinuation of therapy was 56 percent. The study also showed long-term survival outcomes with Opdivo plus Yervoy, regardless of BRAF or lactate dehydrogenase (LDH) status, with four-year OS rates of 62 percent versus 49 percent for patients with normal and elevated LDH, respectively, and four-year OS rates of 54 percent and 61 percent for patients with wild-type and mutant BRAF tumors, respectively.
An analysis exploring long-term quality of life (QoL) and symptom burden in the Phase III CheckMate -067 study found that QoL was maintained during the treatment-free interval – the period where a patient is off study treatment and free of subsequent therapy – in patients with previously untreated unresectable or metastatic melanoma following discontinuation of therapy with Opdivo or Opdivo plus Yervoy. Patient reported outcome scores were maintained from last on-treatment visit to follow-up 1 (30 days after the last dose) or follow-up 2 (84 days after follow-up 1) for patients who discontinued treatment. PRO scores remained stable beyond follow-up 2 for the EQ-5D-3L (measures of mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which were collected at survival follow-up visits every three months in the first year and then every six months.
Additionally, a four-year analysis from the CheckMate -067 study of Opdivo and Yervoy – alone or in combination, in patients with previously untreated unresectable or metastatic melanoma – showed that patient-reported QoL and symptoms were maintained from baseline during extended treatment. Of 813 patients included in the PRO analysis population, QoL – including an assessment of functioning and symptom burden – was maintained for the duration of treatment and in follow-up, with no sustained clinically meaningful deterioration in any treatment arm.
In July, BMS announced that part two of the Phase III CheckMate -227 trial did not meet the primary endpoint of overall survival with Opdivo plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer, regardless of PD-L1 status. The median OS for patients treated with Opdivo plus chemotherapy was 18.83 months versus 15.57 months for chemotherapy, and the landmark one-year OS was 67.3 percent versus 59.2 percent, respectively. In an exploratory analysis of patients with first-line squamous NSCLC, the median OS was 18.27 months for Opdivo plus chemotherapy versus 11.96 months for chemotherapy.
At the same time, the company also announced that part 1a of the CheckMate -227 trial met the co-primary endpoint of OS, demonstrating a statistically significant benefit for Opdivo plus low-dose Yervoy versus chemotherapy in patients whose tumors express PD-L1 ≥1%. In an exploratory analysis of patients in Part 1b whose tumors do not express PD-L1, a survival benefit was also observed with Opdivo plus low-dose Yervoy.
In August, FDA granted Breakthrough Therapy Designation for the investigational agent bempegaldesleukin (NKTR-214) in combination with Opdivo for the treatment of patients with previously untreated unresectable or metastatic melanoma. Bempegaldesleukin, Nektar Therapeutics’ lead immuno-oncology candidate, is an investigational CD122-preferential IL-2 pathway agonist designed to provide activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer cells. A Phase III clinical trial evaluating bempegaldesleukin in combination with Opdivo versus Opdivo in first-line advanced melanoma patients is recruiting patients.
In September, BMS announced that the Phase III CheckMate -548 trial evaluating the addition of Opdivo to the current standard of care (temozolomide and radiation therapy) versus the standard of care alone did not meet one of its primary endpoints, progression-free survival, in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase (MGMT)-methylated. The data monitoring committee recommended that the trial continue as planned to allow the other primary endpoint, overall survival, to mature. The company remains blinded to all study data.
Also in September, BMS announced long-term pooled efficacy and safety results from the Phase III CheckMate -017 and CheckMate -057 studies in patients with previously treated advanced non-small cell lung cancer. At five years, patients treated with Opdivo continued to experience long-term overall survival benefit versus docetaxel. OS rates at five years were 13.4 percent for Opdivo and 2.6 percent for docetaxel. The OS benefit for Opdivo-treated patients was observed across all subgroups. Among patients with an objective response to Opdivo, 32.2 percent continued to see a response at five years. Zero percent of patients with an objective response to docetaxel continued to see a response at five years. The median duration of response was 19.9 months for Opdivo-treated patients and 5.6 months for patients treated with docetaxel.
The anticoagulant Eliquis performed nearly as well as Opdivo in 2018, with sales rising 32.1 percent to $6.44 billion. BMS executives say this was due to market share gains partially offset by lower average net selling prices in the United States, and higher demand attributed to market share gains and growth of the novel oral anticoagulants market internationally. In first-half 2019 Eliquis pushed ahead of Opdivo on BMS’ sales charts, with sales up another 25.7 percent to $3.97 billion.
In March, the BMS-Pfizer Alliance announced results from the Phase IV AUGUSTUS trial evaluating Eliquis versus vitamin K antagonists in patients with non-valvular atrial fibrillation and recent acute coronary syndrome and/or undergoing percutaneous coronary intervention. Results show that in patients receiving a P2Y12 inhibitor with or without aspirin (antiplatelet therapies), the proportion of patients with major or clinically relevant non-major bleeding at six months was significantly lower for those treated with Eliquis compared to those treated with a VKA (10.5 percent versus 14.7 percent, respectively).
The investigators also analyzed the pre-defined secondary composite outcomes of death or hospitalization and death or ischemic events (including myocardial infarction, stroke, definite or probable stent thrombosis, or urgent revascularization). At six months, patients receiving a P2Y12 inhibitor with or without aspirin who were treated with Eliquis had lower rates of death or hospitalization (23.5 percent versus 27.4 percent, respectively) and similar rates of death or ischemic events (6.7 percent versus 7.1 percent, respectively) compared to those assigned to VKA. Patients receiving a P2Y12 inhibitor and an anticoagulant who were treated with aspirin had similar rates of death or hospitalization (26.2 percent versus 24.7 percent, respectively) and similar rates of death or ischemic events (6.5 percent versus 7.3 percent, respectively) compared to those assigned to placebo.
In September, the BMS-Pfizer Alliance announced findings from NAXOS (EvaluatioN of ApiXaban in strOke and Systemic embolism prevention in patients with nonvalvular atrial fibrillation in the real-life setting in France), the largest real-world data analysis on oral anticoagulant effectiveness and safety in Europe among patients with non-valvular atrial fibrillation. NAXOS is a retrospective cohort analysis including nearly all patients in France aged 18 years or older with NVAF newly initiating one of the OACs between 2014 and 2016. In this analysis, Eliquis use was associated with a lower rate of major bleeding compared to a vitamin K antagonist, rivaroxaban, and dabigatran.
In this analysis, Eliquis was also associated with lower rates of stroke and systemic thromboembolic events compared to VKA and rates similar to rivaroxaban or dabigatran. Eliquis was associated with a lower rate of all-cause mortality compared to VKA and rivaroxaban and rates similar to dabigatran.
Orencia, indicated for rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, generated $2.71 billion in sales for BMS in 2018, an improvement of 9.3 percent compared with the previous year. BMS leaders credited this to higher demand and higher average net selling prices in the United States, and higher demand internationally. The product also earned a new indication in Japan during February 2018, for IV treatment of moderate-to-severe polyarticular JIA in patients 2 years of age and older. First-half 2019 sales of Orencia rose another 8.7 percent to $1.42 billion.
In June, BMS announced data from a Phase IV mechanistic study exploring differences in the cellular and molecular mechanisms by which Orencia and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis patients seropositive for certain autoantibodies.
Among 80 adult patients with early (≤ 12 months from symptom onset) moderate-to-severe RA who had never been treated with a biologic medication and tested positive for autoantibodies called anti-citrullinated protein antibody and rheumatoid factor, numerically higher efficacy responses were seen with Orencia at week 24. ACR 20/50/70 responses with Orencia were 83, 70, and 48 respectively; ACR 20/50/70 scores for adalimumab were 63, 45 and 30, respectively. Higher responses were observed in patients with a well-known genetic marker of RA prognosis called the “Shared Epitope” (SE). In SE+ patients, numerically greater efficacy was observed with Orencia; the estimate of difference in the SE+ group for ACR 20 was 28.6; for ACR 50 was 31.5; for ACR 70, 27.6; for DAS28-CRP remission (<2.6), 27.4. Patients in both arms of the study were additionally treated with stable, oral methotrexate weekly.
Rheumatoid factor and ACPA are biomarkers associated with a more severe disease course in RA. The HLA-DRB1 allele, which codes for SE, provides instructions for making a protein that plays a key role in helping the immune system distinguish one’s own proteins from those of harmful invaders, such as bacteria and viruses. Shared Epitope has been shown to be strongly associated with RA, and is thought to be involved with the continuous activation of immune cells, called T cells, that characterizes RA. Shared Epitope is present in 70 to 80 percent of RA patients positive for ACPA.
The oncology product Sprycel brought in $2 billion in sales in 2018, a decline of 0.2 percent year over year. According to company leaders, this decrease was due to inventory workdown offset by higher average net selling prices. During the course of the year Sprycel earned two indication expansions, from FDA to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive ALL in combination with chemotherapy; and from the European Commission to include the treatment of children and adolescents aged 1 year to 18 years old with chronic phase Philadelphia chromosome-positive CML and to include a powder for oral suspension. In the first half of 2019, sales of Sprycel rose 3.1 percent to $1 billion.
In January, FDA expanded the indication for Sprycel tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population. The approval, which was granted following priority review by FDA, is based on data from the Phase II study, CA180-372 (NCT01460160).
The efficacy of Sprycel tablets in combination with chemotherapy was evaluated in a single cohort of the Phase II, multicenter, single-arm CA180-372 study, which included 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL. At three years, the study demonstrated an event-free survival binary rate of 64.1 percent. The European Commission subsequently approved a similar new indication for Sprycel in February, the second pediatric leukemia indication for the drug in Europe.
The oncology product Yervoy earned $1.33 billion in sales for BMS in 2018, an improvement of 6.9 percent year over year. Alongside the drug’s various new approvals in combination with Opdivo, Yervoy also earned a new approval on its own from the European Commission in January 2018, for the treatment of advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older. In the first half of 2019 sales of Yervoy rose an impressive 33.2 percent to $751 million; according to BMS executives, this growth was primarily due to higher demand resulting from the second-quarter 2018 approval of the Opdivo plus Yervoy combination for kidney cancer.
In the pipeline
In August, the European Commission approved Empliciti plus pomalidomide and low-dose dexamethasone (EPd) for treating adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. The approval was based on the ELOQUENT-3 trial in which EPd doubled both median progression-free survival and overall response rate among patients with relapsed and refractory multiple myeloma versus pomalidomide and low-dose dexamethasone alone.
EPd is the first triplet combination approved in Europe based on a randomized clinical trial using the standard of care, Pd, as a comparator. Results from ELOQUENT-3 demonstrated that the addition of Empliciti to Pd can significantly prolong survival without disease progression among heavily pretreated patients with multiple myeloma regardless of the number of prior therapies received. Investigator-assessed PFS, the study’s primary endpoint, was 10.25 months among patients randomized to EPd compared with 4.67 months among patients treated with Pd alone, indicating a 46 percent reduction in risk of disease progression between EPd and Pd arms after a minimum follow-up of 9.1 months. A secondary endpoint of the study, ORR, was 53.3 percent compared with 26.3 percent among patients receiving EPd or Pd, respectively.