On June 1, 2018 Ruth Plummer, MD, PhD, FRCP, reported it will present an abstract describing the first-in-human Phase 1 study of 2X-121, an investigational PARP 1/2 and tankyrase 1/2 inhibitor, as monotherapy in patients with advanced solid tumors (Press release, 2X Oncology, JUN 1, 2018, View Source [SID1234527030]).

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Abstract Title: First-in-human phase 1 study of the PARP/tankyrase inhibitor 2X-121 (E7449) as monotherapy in patients with advanced solid tumors and validation of a novel drug response predictor (DRP) mRNA biomarker.

Abstract No.: 2505

Date: June 1, 2018

Time: 4:09pm CDT

Location: S406

On June 1, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that four posters will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Karyopharm, JUN 1, 2018, View Source [SID1234527027]). Among the poster presentations will be clinical results from the Phase 2 portion of the Company’s Phase 2/3 SEAL study evaluating selinexor, its lead, oral SINE compound, in patients with advanced unresectable dedifferentiated liposarcoma. The remaining posters will highlight data from ongoing investigator-sponsored trials evaluating selinexor in combination with approved anti-cancer agents in hematologic and solid tumor malignancies.

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"In the Phase 2 portion of the SEAL study, patients treated with oral selinexor achieved progression-free survival (PFS) of 5.5 months, compared to 2.7 months for placebo-treated patients, an increase of 2.8 months," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Dedifferentiated liposarcoma is particularly difficult to treat because it is resistant to both standard chemotherapy and radiation and there is a significant unmet need for therapies with a novel mechanism that can help these patients with few effective treatment options. The Phase 3 portion of the SEAL study is currently ongoing and we are anticipating top-line data by the end of 2019. Other selinexor data presented at ASCO (Free ASCO Whitepaper) from ongoing investigator-sponsored research continue to highlight early signs of clinical activity and good tolerability when selinexor is combined with approved agents in soft tissue sarcoma (STS) and acute myeloid leukemia (AML), and additional compelling evidence for selinexor’s potential combinability with checkpoint inhibitors, in this case in AML."

Phase 2 Portion of the Phase 2/3 SEAL Study Evaluating Selinexor in Patients with Liposarcoma

In the poster presentation titled, "Phase 2 results of selinexor in advanced dedifferentiated (DDLS) liposarcoma (SEAL) study: A phase 2/3, randomized, double blind, placebo controlled cross-over study," (Abstract #11512) Mrinal Gounder, MD, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College and lead investigator of the SEAL study, presented detailed clinical data from the successful Phase 2 portion of the randomized, double-blind, placebo-controlled Phase 2/3 SEAL study evaluating oral selinexor (60mg twice weekly) in 56 patients with previously treated, advanced unresectable dedifferentiated liposarcoma (median 2 prior regimens (range 1-9)). Patients on placebo with confirmed progressive disease are permitted to cross over to the selinexor treatment arm.

For the primary endpoint of PFS, oral selinexor showed superiority over placebo, achieving a median PFS of 5.5 months, compared to 2.7 months for placebo with a hazard ratio (HR) of 0.67, representing a 33% reduction in the risk of progression or death. PFS was assessed by Independent Central Radiological Review based on RECIST v1.1. Additional efficacy assessments included PFS by World Health Organization (WHO) response criteria. PFS per WHO criteria achieved a HR of 1.02. Oral selinexor demonstrated an expected and manageable safety profile, primarily with nausea, fatigue, anorexia and weight loss, with low levels of Grade 3/4 cytopenias, and no new or unexpected safety signals identified. The majority of treatment-related adverse events (AEs) were low grade and reversible with dose modifications and/or standard supportive care. These data from the Phase 2 portion of the SEAL study, which is now complete, demonstrate that treatment with selinexor improves PFS (RECIST v1.1) and supports the currently ongoing Phase 3 portion of the study using RECIST v1.1 response criteria [only], and for which top-line data are expected by the end of 2019.

Dr. Gounder stated, "Extending PFS in patients with recurrent, unresectable DDLS is an important clinical goal and these data highlight that oral selinexor continues to demonstrate an expected and manageable safety profile, along with the ability to prolong PFS. We are pleased to share these data with the medical community at ASCO (Free ASCO Whitepaper) this year and look forward to further elucidating selinexor’s efficacy and safety in the already ongoing Phase 3 portion of the SEAL study."

Selinexor in Combination with Immunotherapy or Standard of Care Agents in Other Hematologic and Solid Tumor Malignancies

In the poster presentation titled, "Phase 1b study of selinexor, a first in class selective inhibitor of nuclear export (SINE) compound, in combination with doxorubicin in patients (pts) with locally advanced or metastatic soft tissue sarcoma (STS)," (Abstract #11562) Eoghan Ruadh Malone, MB BCh, BAO, BA, MSc, MRCPI, Princess Margaret Cancer Centre, presented results from an investigator-sponsored Phase 1b clinical study evaluating selinexor in combination with doxorubicin in 17 patients with locally advanced or metastatic STS. Disease subtypes included leiomyosarcoma (n=6), undifferentiated pleomorphic sarcoma (n=3), liposarcoma (n=2), malignant peripheral nerve sheath tumor (n=3) and other sarcomas (n=3). Preliminary data from this study show that the combination of selinexor plus doxorubicin has a manageable tolerability profile, along with early signals of anti-tumor activity, including partial responses (n=3). Median time on treatment is 20 weeks. Enrollment in the study is ongoing.

In the poster presentation titled, "Phase 1 study of selinexor plus mitoxantrone, etoposide, and cytarabine in acute myeloid leukemia," (Abstract #7048) Bhavana Bhatnagar, DO, Ohio State University Comprehensive Cancer Center, presented results from an investigator-sponsored Phase 1 clinical study evaluating selinexor in combination with mitoxantrone, etoposide and cytarabine (MEC) in patients with relapsed or refractory AML. Of the 23 evaluable patients, ten responded for an overall response rate of 44%, including six patients (26%) achieving complete remission (CR), two patients (9%) achieving CR with incomplete count recovery (CRi), and two patients (9%) achieving a morphologic leukemia-free state (MLFS). The tolerability of this combination regimen was similar to cytotoxic chemotherapy alone. The most common Grade ≥3 adverse events were febrile neutropenia (48%), catheter related infection (26%), diarrhea (26%), hyponatremia (22%), sepsis (22%), fatigue (13%), hyperglycemia (13%), and hypotension (13%). The RP2D of selinexor in in this combination regimen was established to be 60mg twice weekly. Six responders proceeded to allogeneic stem cell transplantation without evidence of AML at the time of transplant.

In the poster presentation titled, "Profiling the immune checkpoint pathway in acute myeloid leukemia," (Abstract #7015) Paola Dama, PhD, University of Chicago, presented results from an investigator-sponsored study assessing the expression of immune checkpoint biomarkers in AML patients treated with the combination of selinexor, high-dose cytarabine (HiDAC) and mitoxantrone. Data from this study demonstrated high level expression of Gal9 in CD34- cells at diagnosis in patients who failed induction chemotherapy, compared to those in complete remission. There was no difference in PD-L1 expression between the two patient groups. Increased expression of Tim 3 on CD4 and CD8 T cells and high PD-1 in peripheral CD4+ T cell were observed at disease remission suggesting an exhausted immune status at the time of disease remission on the selinexor + HiDAC + mitoxantrone combination, which the researchers believe could be targeted with the addition of checkpoint inhibitors.

Details for the ASCO (Free ASCO Whitepaper) 2018 selinexor presentations are as follows:

Company-sponsored Trials

Title:Phase 2 results of selinexor in advanced de-differentiated (DDLS) liposarcoma (SEAL) study: A phase 2/3, randomized, double blind, placebo controlled cross-over study
Lead author:Mrinal Gounder, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Poster Board #: 257
Abstract #: 11512
Poster Discussion Session: Sarcoma
Poster Discussion Presenter:Mark Andrew Dickson
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT; Discussion from 3:18 – 3:30PM CT
Location: Hall A

Investigator-sponsored Trials

Title:Phase 1 study of selinexor plus mitoxantrone, etoposide, and cytarabine in acute myeloid leukemia
Lead author:Bhavana Bhatnagar, Ohio State University Comprehensive Cancer Center
Poster Board #: 108
Abstract: 7048
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A

Title:Phase 1b study of selinexor, a first in class selective inhibitor of nuclear export (SINE) compound, in combination with doxorubicin in patients (pts) with locally advanced or metastatic soft tissue sarcoma (STS)
Lead author: Eoghan Ruadh Malone, Princess Margaret Cancer Centre
Poster Board #: 307
Abstract: 11562
Poster Session: Sarcoma
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A

Title:Profiling the immune checkpoint pathway in acute myeloid leukemia
Lead author:Paola Dama, University of Chicago
Poster Board #: 75
Abstract: 7015
Poster Discussion Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT; Discussion from 11:30 AM – 12:45 PM CT
Location: Hall A

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On June 1, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conferences during June and invited investors to participate by webcast (Press release, Exact Sciences, JUN 1, 2018, View Source [SID1234527026]).

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Jefferies 2018 Global Healthcare Conference, New York Presentation on Tuesday, June 5, 2018, at 9 a.m. EDT

William Blair 38th Annual Growth Stock Conference, Chicago Presentation on Tuesday, June 12, 2018, at 4:10 p.m. CDT

Goldman Sachs 39th Annual Global Healthcare Conference, Rancho Palos Verdes, Calif. Fireside chat on Wednesday, June 13, 2018, at 8 a.m. PDT

On June 1, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, reported financial results for the three months ended March 31, 2018 and provided clinical and corporate updates (Press release, Can-Fite BioPharma, JUN 1, 2018, View Source [SID1234527025]).

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Clinical Development Program and Corporate Highlights Include:

Piclidenoson (CF101) – Can-Fite continues Phase III trial of Piclidenoson in the treatment of rheumatoid arthritis and signed multi-million dollar distribution agreement with Gebro Holdings for Piclidenoson in three European countries
Rheumatoid Arthritis: In January 2018, Can-Fite signed a distribution agreement with Gebro Holding GmBH to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of rheumatoid arthritis and psoriasis, in three European countries (Spain, Switzerland and Austria), upon receipt of regulatory approvals. Under the terms of the distribution agreement, Gebro is required to pay additional milestone payments of up to $7,000,000 upon the achievement of certain regulatory, launch and sales milestones plus double-digit percentage royalty payments on net sales.

Rheumatoid arthritis is a treatment market forecast to reach $34.6 billion by 2020.

Psoriasis: In April 2018, Can-Fite published a paper titled "Inhibition of IL-17 and IL-23 in Human Keratinocytes by the A3 Adenosine Receptor Agonist Piclidenoson" (View Source) in the Journal of Immunology Research. The Company has completed the preparatory work for its COMFORT Phase III Psoriasis study, designed to evaluate the efficacy and safety of daily Piclidenoson, administered orally compared to Apremilast (Otezla) and placebo in around 400 patients with moderate-to-severe plaque psoriasis. The study will be conducted in 5 countries in Europe, Israel and Canada. The study protocol has been already submitted and approved by the IRB in Israel, which will be the first country to initiate enrollment.

The psoriasis therapeutic market is estimated to reach $11.4B in 2020 according to Visiongain.

Namodenoson (CF102) – Can-Fite global Phase II advanced liver cancer study is fully enrolled; Potentially favorable drug safety profile has been reported; The Company continues to follow up on patients’ overall survival
Advanced Liver Cancer: During the fourth quarter of 2017, Can-Fite reported on the progress of its Phase II liver cancer study with Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC) indicating a potentially favorable drug safety profile. The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child-Pugh Class B, who failed Nexavar (sorafenib) as a first-line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is overall survival (OS). Secondary endpoints include progression free survival (PFS), safety, and the relationship between outcomes and A3 adenosine receptor expression. The Company anticipates data release to occur in 2H2018.

According to Datamonitor, the HCC market is expected to generate $1.4 billion in sales in 2019.

NAFLD/NASH:

Phase II clinical study – The Company is currently conducting a Phase II trial with its drug candidate Namodenoson for the treatment of 60 patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). There is currently no U.S. FDA-approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.

New pre-clinical data – In February 2018, Can-Fite announced new preclinical data supporting a novel anti-NASH mechanism of action for Namodenoson. Preclinical studies were conducted in hepato-stellate cells in vitro and in an experimental NASH CCL4 model, showing that in both systems, the molecular mechanism of action of Namodenoson is conferred by decreased expression levels of the signaling protein phosphoinositol-3-phosphate (PI3K) which confers three downstream signal transduction pathways, the Wnt, NF-kB and α-SMA, altogether, controlling liver inflammation, fibrosis and steatosis. The data were presented at the European Association for the Study of the Liver (EASL) annual conference.

"We continue to build positive momentum with our drug candidates. We also secured a significant distribution agreement with Gebro Holding GmBH to distribute Piclidenoson for the treatment of rheumatoid arthritis and psoriasis in three European countries. This quarter we also submitted our annual safety summaries on both Piclidenoson and Namodenoson to regulatory authorities around the world and were pleased to note that both drug candidates continue to demonstrate a favorable safety profile in human clinical trials. We look forward to providing updates on our Phase II study on Namodenoson during the second half of the year," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Change in Functional and Presentation Currency

From the Company’s inception through January 1, 2018, the Company’s functional and presentation currency was the New Israeli Shekel (NIS). Management conducted a review of the functional currency of the Company and decided to change its functional and presentation currency to the U.S. dollar from the NIS effective January 1, 2018. This change was based on an assessment by Company management that the dollar is the primary currency of the economic environment in which the Company operates. Accordingly, the functional and presentation currency of the Company in the financial results presented in this press release is the U.S. dollar.

In determining the appropriate functional currency to be used, the Company followed the guidance in International Accounting Standard (IAS) 21, which states that factors relating to sales, costs and expenses, financing activities and cash flows, as well as other potential factors, should be considered. In this regard, the Company is incurring and expects to continue to incur a majority of its expenses in U.S. dollars as a result of its expanded clinical trials. These changes, as well as the fact that the majority of the Company’s available funds are in U.S. dollars, the Company’s principal source of financing is the U.S. capital market, and all of the Company’s budgeting is conducted solely in U.S. dollars, led to the decision to make the change in functional currency as of January 1, 2018, as indicated above.

For presentation purposes, comparative figures in the financial results have been translated into dollars on the following basis: (i) monetary assets and liabilities of the Company were translated using the current rate method, using the dollar exchange rate as of December 31, 2017, (ii) non-monetary assets and liabilities of the Company and equity were translated using historical exchange rates at the relevant transaction dates, (iii) profit and loss accounts were recorded at the exchange rate at the date of the transaction, and (iv) translation differences resulting from the change in functional currency have been reported as a component of shareholders’ equity.

Revenues for the three months ended March 31, 2018 were U.S. $0.63 million compared to revenues of U.S. $0.07 million during the three months ended March 31, 2017. The increase in revenues for the first quarter of 2018 was mainly due to the recognition of a portion of the U.S. $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro Holding GmbH.

Research and development expenses for the three months ended March 31, 2018 were U.S. $1.31 million compared with U.S. $1.22 million for the same period in 2017. Research and development expenses for the first quarter of 2018 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. The Company expects that the research and development expenses will increase through 2018 and beyond.

General and administrative expenses were U.S. $0.90 million for the three months ended March 31, 2018 compared to U.S. $0.76 million for the same period in 2017. The increase is primarily due to an increase in investor relations expenses. We expect that the annual general and administrative expenses will remain at the same level as 2017.

Financial expense, net for the three months ended March 31, 2018 aggregated U.S. $0.13 million compared to financial income, net of U.S. $0.17 million for the same period in 2017. The increase in financial expense, net in the first quarter of 2018 was mainly due to an increase in interest expenses related to advance payment recognition and an increase in exchange rate differences on balances of cash and cash equivalents.

Can-Fite’s net loss for the three months ended March 31, 2018 was U.S. $1.72 million compared with a net loss of U.S. $1.74 million for the same period in 2017. The slight difference in net loss for the first quarter of 2018 was primarily attributable to an increase in revenues, which was offset by an increase in general and administrative expenses and in financial expenses, net.

As of March 31, 2018, Can-Fite had cash and cash equivalents of U.S. $8.31 million as compared to U.S. $3.5 million at December 31, 2017. The increase in cash during the three months ended March 31, 2018 is due to U.S. $4.37 million received from the issuance of shares and warrants, net of issuance expenses, and the $2.2 million advance payment received from Gebro.

The Company’s consolidated financial results for the three months ended March 31, 2018 are presented in accordance with International Financial Reporting Standards.

On June 1, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported patient-reported outcomes data from the Phase 3 CheckMate -214 trial in intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC) treated with the Immuno-Oncology combination Opdivo (nivolumab) plus low-dose (1mg/kg) Yervoy (ipilimumab) versus sunitinib over a two-year follow-up period (Press release, Bristol-Myers Squibb, JUN 1, 2018, View Source [SID1234527024]). 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.

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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 (P<0.05). Time to deterioration (TTD) in FKSI-19 total score was also significantly delayed with Opdivo plus low-dose Yervoy versus sunitinib (HR 0.54; 95% CI, 0.46–0.63; P < 0.0001).

An additional analysis showed similar results with a significant benefit seen for Opdivo plus low-dose Yervoy relative to sunitinib on change from baseline at a pre-planned 25-week landmark. Assessed by FKSI-19 total score, with a mean difference of 3.55 (1.65 vs -1.9; P<0.0001), the analysis showed that patients in the Opdivo plus low-dose Yervoy arm experienced significantly better health-related quality of life scores in regard to disease-related symptoms, treatment side effects and functioning.

Additionally, longitudinal changes from baseline in health-related quality of life between treatment arms at 25 weeks, as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G), also demonstrated a significant advantage for Opdivo plus low-dose Yervoy, with a mean difference of 3.71 (1.52 vs -2.19; P<0.0009) in the total score between arms. Confirmatory results from FACT-G also showed significantly higher scores in the combination arm across a number of measures, including physical, functional and emotional well-being. Collectively, these data suggest a significant and consistent patient reported benefit of the combination relative to standard of care.

"With CheckMate -214, for patients with advanced renal cell carcinoma, we have previously seen the efficacy benefit of Opdivo plus low-dose Yervoy across a number of measures, including overall survival, objective response rate and progression-free survival," said David Cella, Ph.D., chair, Department of Medical Social Sciences, and director, Institute for Public Health and Medicine – Center for Patient-Centered Outcomes, Northwestern University Feinberg School of Medicine, Chicago. "What we now add with this analysis is evidence that patients treated with this Immuno-Oncology combination also reported significant improvements in disease-related symptoms, as well as positive changes to their physical, emotional and functional well-being."

John O’Donnell, MPP, Ph.D., vice president, worldwide health economics and outcomes research, Bristol-Myers Squibb, said, "The analysis of patient-reported outcomes in CheckMate -214 is particularly relevant for patients with advanced renal cell carcinoma as it shows that the combination of Opdivo plus low-dose Yervoy not only provides therapeutic benefits over a current standard of care but it demonstrates improvements in patient health-related quality of life that were sustained over the two-year follow-up period. These results attest to our leadership in Immuno-Oncology and our commitment to providing physicians with treatment options that make a difference in patients’ lives."

Findings will be presented during the Developmental Therapeutics—Immunotherapy poster session on Monday, June 4 from 8:00-11:30 AM CDT at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2018 in Chicago (Abstract #3073).

About CheckMate -214

CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced RCC. In the intermediate- and poor-risk study population, 425 patients received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses, followed by Opdivo 3 mg/kg every two weeks, and 422 patients received sunitinib 50 mg once daily for four weeks, followed by two weeks off every cycle. The recommended dosing for the Opdivo plus Yervoy combination is Opdivo 3 mg/kg followed by Yervoy 1 mg/kg each infused intravenously over 30 minutes on the same day every three weeks for four doses. After completing four doses of the combination, Opdivo should be administered intravenously 240 mg every two weeks or 480 mg every four weeks over 30 minutes until disease progression or unacceptable toxicity.

The primary efficacy outcome measures of the trial were OS, ORR (CR+PR) and PFS as determined by an independent radiographic review committee (IRRC) in intermediate- and poor-risk patients. Patients were included regardless of their PD-L1 status. Data from CheckMate -214 were previously presented at the European Society for Medical Oncology Congress in September 2017 and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2017 and were published in the New England Journal of Medicine in March 2018.

About Renal Cell Carcinoma

Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for nearly 15,000 deaths in the United States each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 70% to 80% of all patients. Renal cell carcinoma is approximately twice as common in men as in women. In the United States, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 8%.