On April 26, 2018 Exelixis, Inc. (NASDAQ:EXEL) reported that data from clinical trials of cabozantinib will be the subject of 15 presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1-5, 2018 (Press release, Exelixis, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344886 [SID1234525739]).

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Poster presentations will include detailed subset results from the CELESTIAL phase 3 pivotal trial in advanced hepatocellular carcinoma (HCC) comparing outcomes by age and in patients whose only prior treatment was sorafenib. CELESTIAL was the basis for Exelixis’ supplemental New Drug Application filed with the U.S. Food and Drug Administration for CABOMETYX (cabozantinib) tablets as a treatment for patients with previously treated advanced HCC. Additionally, longer follow-up data from the phase 1 trial of cabozantinib in combination with nivolumab with or without ipilimumab in patients with metastatic genitourinary cancers will be featured, along with preliminary safety and efficacy data on cabozantinib plus nivolumab in patients with metastatic urothelial carcinoma refractory to checkpoint inhibitor therapy.

"We’re excited about the potential of cabozantinib, both alone and in combination with other therapies, across a range of difficult-to-treat cancers and look forward to presenting data from our clinical trials in genitourinary cancers, advanced hepatocellular carcinoma and other tumor types," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Our data at ASCO (Free ASCO Whitepaper) underscore our dedication to maximizing results and expanding possibilities for people living with many different cancer types."

Cabozantinib to be featured in 15 presentations
The full schedule of cabozantinib presentations expected at the meeting is as follows:

Poster Discussion

[Abstract 4019] "Cabozantinib (C) versus Placebo (P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC) who have Received Prior Sorafenib: Results from the Randomized Phase 3 CELESTIAL Trial"
Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A
Discussed at the Poster Discussion Session on Sunday, June 3, 4:45 – 6:00 p.m., CDT, Hall D2

Poster Presentations

[Abstract 4528] "Clinical Efficacy Of Cabozantinib Plus Nivolumab (CaboNivo) and CaboNivo Plus Ipilimumab (CaboNivoIpi) in Patients (pts) with Chemotherapy-refractory Metastatic Urothelial Carcinoma (mUC) either Naïve (n) or Refractory (r) to Checkpoint Inhibitor (CPI)"
Rosa Maria Nadal, M.D., M.D., Ph.D., National Cancer Institute, National Institutes of Health
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 4556] "Quality-Adjusted Time without Symptoms or Toxicity (Q-TWiST): Analysis of Cabozantinib (Cabo) vs Sunitinib (Sun) in Patients with Advanced Renal Cell Carcinoma (aRCC) of Intermediate or Poor Risk (Alliance A031203)"
Ronald C. Chen, M.D., MPH, University of North Carolina at Chapel Hill
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 4579] "Cabozantinib (Cabo) in Advanced Non-clear Cell Renal Cell Carcinoma (nccRCC): A Retrospective Multicenter Analysis"
Nieves Martinez Chanza, Dana-Farber Cancer Institute
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4593] "A Phase I-II Study to Evaluate Safety and Efficacy of the Combination of Niraparib plus Cabozantinib in Patients with Advanced Kidney/Urothelial Carcinoma"
Daniel E. Castellano, M.D., Hospital 12 de Octubre
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4598] "A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib vs Sunitinib in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (RCC; CheckMate 9ER)"
Toni K. Choueiri, M.D., Dana-Farber Cancer Institute
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4601] "CANTATA: A Randomized Phase 2 Study of CB-839 in Combination with Cabozantinib vs. Placebo with Cabozantinib in Patients with Advanced/Metastatic Renal Cell Carcinoma"
Nizar M. Tannir, M.D., FACP, The University of Texas MD Anderson Cancer Center
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4603] "CABOPRE: Phase II Study of Cabozantinib Prior to Cytoreductive Nephrectomy (CN) in Locally Advanced and/or Metastatic Renal Cell Carcinoma (mRCC)"
Guillermo de Velasco, M.D., Ph.D., Department of Medical Oncology, University Hospital 12 de Octubre, i + 12, Madrid, Spain
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 1026] "A Phase II Study of Cabozantinib (Cabo) Alone or in Combination with Trastuzumab (T) in Patients (pts) with Breast Cancer Brain Metastases (BCBM)"
Jose Pablo Leone, M.D., Dana-Farber Cancer Institute
Session: Breast Cancer – Metastatic
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS1119] "A Phase II Study of Nivolumab in Combination with Cabozantinib for Metastatic Triple-Negative Breast Cancer (mTNBC)"
Romualdo Barroso-Sousa, M.D., Ph.D., Dana-Farber Cancer Institute
Session: Breast Cancer – Metastatic
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 6088] "A Phase II Trial of Cabozantinib (CABO) for the Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid Carcinoma (DTC) in the First-line Setting"
Marcia S. Brose, M.D., Ph.D., Department of Otorhinolaryngology, Head and Neck Surgery and the Abramson Cancer Center of the University of Pennsylvania
Session: Head and Neck Cancer
Poster presented Saturday, June 2, 1:15 – 4:45 p.m. CDT, Hall A

[Abstract 3555] "A Phase I/II Trial of Cabozantinib (C) with or without Panitumumab (P) in Patients (pts) with RAS Wild-Type (WT) Metastatic Colorectal Cancer (mCRC): Clinical Outcomes in Pts with MET Amplification (amp) Detected in Blood"
Jingquan Jia, M.D., Ph.D., Duke University Medical Center
Session: Gastrointestinal (Colorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

[Abstract 4088] "Outcomes in Patients (pts) who had Received Sorafenib (S) as the Only Prior Systemic Therapy in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Advanced Hepatocellular Carcinoma (HCC)"
Robin Kate Kelley, M.D., University of California San Francisco
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

[Abstract 4090] "Outcomes Based on Age in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC)"
Lorenza Rimassa, M.D., Humanitas Clinical and Research Center
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

[Abstract TPS4157] "A Phase II Trial of Cabozantinib and Erlotinib for Patients with EGFR and c-MET Co-expressing Metastatic Pancreatic Adenocarcinoma"
Olumide B. Gbolahan, MBBS, Indiana University School of Medicine
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

About the CELESTIAL Study
CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who received prior sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and/or macrovascular invasion (yes or no). No cross-over was allowed between the study arms during the blinded treatment phase of the trial. The primary endpoint for the trial is overall survival, and secondary endpoints include objective response rate and progression-free survival. Exploratory endpoints include patient-reported outcomes, biomarkers and safety.

About Genitourinary Cancers
Genitourinary cancers are those that affect the urinary tract, bladder, kidneys, ureter, prostate, testicles, penis or adrenal glands — parts of the body involved in reproduction and excretion — and include renal cell carcinoma (RCC) and urothelial carcinoma.1

The American Cancer Society’s 2018 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease.4 Approximately 30,000 patients in the U.S. and 70,000 globally require treatment.5

Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.6 Urothelial carcinoma occurs mainly in older people; 90 percent of patients with bladder cancer are 55 years or older.7 Bladder cancer is the fourth most common cancer in men and accounts for about five percent of all new cases of cancer in the U.S. each year.7,8 In 2015, an estimated 708,000 people were living with bladder cancer in the U.S.8

About HCC
Liver cancer is the second-leading cause of cancer death worldwide, accounting for more than 700,000 deaths and nearly 800,000 new cases each year.9 In the U.S., the incidence of liver cancer has more than tripled since 1980.2 HCC is the most common form of liver cancer, making up about three-fourths of the estimated nearly 42,000 new cases in the U.S. in 2018. HCC is the fastest-rising cause of cancer-related death in U.S.10 Without treatment, patients with advanced HCC usually survive less than 6 months.11

About CABOMETYX (cabozantinib)
CABOMETYX tablets are approved in the United States for the treatment of patients with advanced RCC. CABOMETYX tablets are also approved in the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy. Ipsen also submitted to the EMA the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017; on March 23, 2018, the CHMP provided a positive opinion for CABOMETYX for the first-line treatment of intermediate- or poor-risk advanced RCC. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan, including RCC.

Please see Important Safety Information below and full U.S. prescribing information at View Source

U.S. Important Safety Information

Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic events was 3% in CABOMETYX-treated patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were reported in 1% of CABOMETYX-treated patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were reported in 1% of CABOMETYX-treated patients. Monitor patients for symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula which cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. In RCC studies, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: In RCC studies, diarrhea occurred in 74% of patients treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity may be associated with CABOMETYX. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.
Please see accompanying full Prescribing Information View Source

On April 26, 2018 Novocure (NASDAQ: NVCR) reported financial results for the quarter and year ended March 31, 2018, highlighting year-over-year growth in active patients and net revenues (Press release, NovoCure, APR 26, 2018, View Source [SID1234525761]). Novocure is a global oncology company developing a proprietary platform called Tumor Treating Fields for the treatment of solid tumor cancers. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die.

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An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(2) A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

"We are pleased with our continued commercial momentum during the first quarter 2018. Our ongoing sales and marketing efforts, the December 2017 publication of final EF-14 analysis in JAMA and our strong presence at SNO in November 2017 all contributed to growing awareness and confidence in Optune," said Asaf Danziger, Novocure’s Chief Executive Officer. "We had more than 2,000 patients on therapy at quarter end, representing thirteen consecutive quarters of active patient growth since the initial presentation of our EF-14 data in newly diagnosed glioblastoma. We delivered $52.1 million in first quarter 2018 revenues and approached $200 million in trailing twelve-month revenues, further establishing our position as a global oncology company with increasing commercial scale."

"In March 2018, the National Comprehensive Cancer Network (NCCN) updated its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Central Nervous System Cancers to include alternating electric field therapy as a category 1 treatment for newly diagnosed glioblastoma in combination with temozolomide after maximal safe resection and completion of radiation therapy in March 2018," continued Mr. Danziger. "We believe the updated NCCN guidelines will further increase physician awareness, especially in the radiation oncology and medical oncology communities, helping us to reach patients earlier in the course of this aggressive disease."

"I am very pleased to announce that last week we reported positive top-line results from our STELLAR phase 2 pilot trial in mesothelioma. These results exceeded the results of the interim analysis for all efficacy endpoints and demonstrated clinically meaningful improvements in overall survival and progression free survival," added William Doyle, Novocure’s Executive Chairman. "Mesothelioma is the first indication outside of the brain for which Novocure will pursue FDA approval."

"We believe a significant opportunity remains to increase penetration and reimbursement in our active GBM markets and to expand into additional geographic markets. In parallel, we will advance our clinical pipeline in additional indications with high unmet needs," noted Mr. Doyle. "With more than $216 million cash on hand at the end of the quarter, we believe we are in a position of strength to continue to execute our two-pronged strategy."

First quarter 2018 operating statistics and financial update

There were 2,009 active patients on Optune at March 31, 2018, representing 59 percent growth versus March 31, 2017, and 10 percent growth versus December 31, 2017. The increase in active patients was driven primarily by prescription growth and by an increase in the percentage of active patients with a newly diagnosed GBM diagnosis who typically have a longer duration of treatment with Optune. In the first quarter 2018, approximately two-thirds of Optune prescriptions were written for newly diagnosed GBM.

In the United States, there were 1,445 active patients on Optune at March 31, 2018, representing 55 percent growth versus March 31, 2017.
In Germany and other EMEA markets, there were 544 active patients on Optune at March 31, 2018, representing 64 percent growth versus March 31, 2017.
In Japan, there were 20 active patients on Optune at March 31, 2018, representing 900 percent growth versus March 31, 2017.
Additionally, 1,258 prescriptions were received in the three months ended March 31, 2018, representing 41 percent growth compared to the same period in 2017, and 15 percent growth versus the three months ended December 31, 2017. The increase in prescriptions was driven primarily by commercial activities in our currently active markets.

In the United States, 946 prescriptions were received in the three months ended March 31, 2018, representing 38 percent growth compared to the same period in 2017.
In Germany and other EMEA markets, 282 prescriptions were received in the three months ended March 31, 2018, representing 37 percent growth compared to the same period in 2017.
In Japan, 30 prescriptions were received in the three months ended March 31, 2018, representing 900 percent growth compared to the same period in 2017.
For the three months ended March 31, 2018, net revenues were $52.1 million, representing 49 percent growth versus the same period in 2017. Revenue growth was primarily driven by increased Optune adoption in the United States and Germany and initial launch efforts Japan, partially offset by the absence of one-time benefits from the 2017 cash to accrual revenue recognition transition.

For the three months ended March 31, 2018, cost of revenues was $18.2 million compared to $11.7 million for the same period in 2017, representing an increase of 56 percent. The increase was primarily driven by the cost of shipping transducer arrays to a higher volume of commercial patients, as well as an increase in field equipment depreciation.

Research, development and clinical trials expenses for the three months ended March 31, 2018, were $11.1 million compared to $9.4 million for the same period in 2017, representing an increase of 18 percent. This was primarily due to an increase in clinical trial and personnel expenses for our LUNAR, METIS, and PANOVA trials and an increase in investigator sponsored trial costs.

Sales and marketing expenses for the three months ended March 31, 2018, were $18.1 million compared to $14.8 million for the same period in 2017, representing an increase of 23 percent. This was primarily due to increased marketing expenses, increased personnel and facility expenses to support our geographical expansion in Japan and Austria and an increase in share-based compensation.

General and administrative expenses for the three months ended March 31, 2018, were $17.3 million compared to $12.4 million for the same period in 2017, representing an increase of 39 percent. This was primarily due to increase in share-based compensation.

Personnel costs for the three months ended March 31, 2018, included $8.5 million in non-cash share-based compensation expenses, comprised of $0.2 million in cost of revenues; $0.9 million in research, development and clinical trials; $1.4 million in sales and marketing; and $6.0 million in general and administrative expenses. Total non-cash share-based compensation expenses for the first quarter 2017 were $4.6 million.

Net loss for the three months ended March 31, 2018, was $20.7 million compared to net loss of $18.0 million for the same period in 2017, representing a decline of 15 percent.

At March 31, 2018, we had $111.6 million in cash and cash equivalents and $104.7 million in short-term investments, for a total balance of $216.3 million in cash, cash equivalents and short-term investments.

Anticipated clinical trial milestones

Phase 2 pilot STELLAR trial in mesothelioma data presentation (2H 2018)
Initiation of phase 3 pivotal trial in recurrent ovarian cancer (2H 2018)
Data collection from phase 3 pivotal METIS trial in brain metastases (2020)
Data collection from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Data collection from phase 3 pivotal PANOVA 3 trial in locally advanced pancreatic cancer (2022)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2018 financial results today, Thursday, April 26, 2018, at 8 a.m. EDT. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 2384187.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call.

Upcoming investor events

Novocure will be participating in two investor conferences in May. Dr. Eilon Kirson, Novocure’s Chief Scientific Officer and Head of Research and Development, will participate in a fireside chat at the Deutsche Bank 43rd Annual Healthcare Conference on May 9, 2018, in Boston. Dr. Kirson’s presentation will begin at 8:40 a.m. EDT and will be followed by a Q&A session.

Additionally, William Doyle, Novocure’s Executive Chairman, will participate in the UBS 2018 Global Healthcare Conference on May 22, 2018, in New York. Mr. Doyle’s presentation will begin at 8:30 a.m. EDT and will be followed by a Q&A session.

Live audio webcasts of these presentations can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the relevant presentation.

On April 26, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the first quarter of 2018 which were highlighted by strong sales for Opdivo , Eliquis , and Orencia , important regulatory progress in Immuno-Oncology and strategic business development transactions (Press release, Bristol-Myers Squibb, APR 26, 2018, View Source [SID1234525719]).

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"We delivered strong commercial performance with continued growth for our key franchises, Opdivo and Eliquis, and obtained FDA approval for Opdivo plus Yervoy in renal cell carcinoma, a disease with high unmet need which represents an important opportunity for the company," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. "I am confident that strong commercial execution, upcoming Phase 3 readouts across our oncology pipeline and continued strategic use of business development position us well for future growth."

FIRST QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted first quarter 2018 revenues of $5.2 billion, an increase of 5% compared to the same period a year ago. Revenues increased 1% when adjusted for foreign exchange impact.
U.S. revenues increased 1% to $2.8 billion in the quarter compared to the same period a year ago. International revenues increased 10%. When adjusted for foreign exchange impact, international revenues increased 1%.
Gross margin as a percentage of revenue decreased from 74.3% to 69.5% in the quarter primarily due to product mix.
Marketing, selling and administrative expenses decreased 10% to $980 million in the quarter.
Research and development expenses decreased 4% to $1.3 billion.
The effective tax rate was 16.0% in the quarter, compared to 21.9% in the first quarter last year.
The company reported net earnings attributable to Bristol-Myers Squibb of $1.5 billion, or $0.91 per share, in the first quarter compared to net earnings of $1.6 billion, or $0.94 per share, for the same period in 2017.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.5 billion, or $0.94 per share, in the first quarter, compared to $1.4 billion, or $0.84 per share, for the same period in 2017. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.
Cash, cash equivalents and marketable securities were $9.0 billion, with a net cash position of $1.3 billion, as of March 31, 2018.
FIRST QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

Global revenues for prioritized brands increased in the first quarter of 2018 by 21% compared to the first quarter of 2017, driven by:

In April, the European Commission approved an every four-week Opdivo dosing schedule of 480 mg infused over 60 minutes as an option for patients with advanced melanoma and previously treated renal cell carcinoma (RCC) as well as the approval of a two-week Opdivo flat dose option of 240 mg infused over 30 minutes to replace weight-based dosing for all six approved monotherapy indications in the European Union.
In April, the company announced the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date is August 16, 2018.
In April, the company announced the FDA approved the combination of Opdivo plus Yervoy for previously untreated patients with intermediate- and poor-risk advanced RCC.
In March, the company announced the FDA accepted for priority review a sBLA for the Opdivo plus Yervoy combination for the treatment of adults 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. The FDA action date is July 10, 2018.
In March, the company announced the FDA approved a sBLA updating the Opdivo dosing schedule to include 480 mg infused every four weeks for a majority of approved indications as well as a shorter 30 minute infusion across all approved indications.
Clinical

In April, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the company presented results from numerous studies of novel agents and Opdivo-based combinations. Key clinical data presented at the meeting include:
CheckMate -227: First presentation of data from the Phase 3 study assessing the Opdivo plus Yervoy combination versus platinum-doublet chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (≥10 mutations/megabase). (link)
CheckMate -568: First presentation of data from a Phase 2 study evaluating Opdivo plus Yervoy in treatment naïve patients with advanced NSCLC. Results demonstrated Opdivo 3 mg/kg plus low-dose Yervoy (1mg/kg) identified high tumor mutational burden of ≥10 mutations/megabase (mut/Mb) as an effective cutoff for selecting which patients were most likely to respond to first-line treatment of Opdivo plus Yervoy regardless of tumor PD-L1 expression.
CheckMate -078: First presentation of data from the Phase 3 study evaluating Opdivo monotherapy versus docetaxel in a predominantly Chinese patient population with previously treated advanced NSCLC. (link)
CheckMate -141: Announced a two-year overall survival (OS) update from the Phase 3 study evaluating patients treated with Opdivo over standard of care in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after failure on platinum-based therapy. (link)
Eliquis

Clinical

In March, at the American College of Cardiology’s 67th Annual Scientific Session & Expo, the company and Pfizer Inc. announced the largest real-world data analysis from studies evaluating different direct oral anticoagulants, including Eliquis, rivaroxaban and dabigatran, for non-valvular atrial fibrillation patients. (link)
FIRST QUARTER BUSINESS DEVELOPMENT UPDATE

In April, the company and Illumina, Inc. announced a collaboration that will utilize Illumina’s next-generation sequencing technology to develop and globally commercialize in-vitro diagnostic assays in support of Bristol-Myers Squibb’s oncology portfolio.
In April, the company and Janssen Pharmaceutical Companies of Johnson & Johnson announced a worldwide collaboration to develop and commercialize Bristol-Myers Squibb’s Factor Xia inhibitor program, including BMS-986177, an anticoagulant compound being studied for prevention and treatment of major thrombotic conditions.
In April, the company 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.
In February, the company announced that Yale Cancer Center will join the International Immuno-Oncology Network, a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance translational Immuno-Oncology science.
In February, the company and Nektar Therapeutics announced a global strategic development and commercialization collaboration for Nektar’s lead Immuno-Oncology program, NKTR-214. The companies will jointly develop and commercialize NKTR-214 in combination with Opdivo and Opdivo plus Yervoy in more than 20 indications across nine tumor types.
2018 FINANCIAL GUIDANCE

Bristol-Myers Squibb is decreasing its 2018 GAAP EPS guidance range from $3.00 – $3.15 to $2.70 – $2.80 and increasing its non-GAAP EPS guidance range from $3.15 – $3.30 to $3.35 – $3.45. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2018 GAAP and non-GAAP line-item guidance assumptions are:

Worldwide revenues increasing in the mid-single digits.
Research and development expenses increasing in the low-single digits for GAAP.
An effective tax rate between 17% and 18% for both GAAP and non-GAAP.
The financial guidance for 2018 excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2018 guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information." Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are provided in supplemental materials available on the company’s website.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information, that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods including restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges in connection with the acquisition or licensing of third party intellectual property rights, divestiture and equity investment gains or losses, upfront payments from out-licensed assets, pension charges, legal and other contractual settlements and debt redemption gains or losses, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP.

Statement on Cautionary Factors

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. These statements may be identified by the fact that they use words such as "anticipate", "estimates", "should", "expect", "guidance", "project", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, effects of the continuing implementation of governmental laws and regulations related to Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. These factors also include the company’s ability to successfully execute its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products, including assumptions about the company’s ability to retain patent exclusivity of certain products, and the impact and result of governmental investigations. There can be no guarantees with respect to pipeline products that future clinical studies will support the data described in this release, that the compounds will receive necessary regulatory approvals, or that they will prove to be commercially successful; nor are there guarantees that regulatory approvals will be sought, or sought within currently expected timeframes, or that contractual milestones will be achieved. For further details and a discussion of these and other risks and uncertainties, see the company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Company and Conference Call Information

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

There will be a conference call on April 26, 2018 at 10:30 a.m. EDT during which company executives will review financial information and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at View Source or by calling the U.S. toll free 866-548-4713 or international 323-794-2093, confirmation code: 4713257. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 1:30 p.m. EDT on April 26, 2018 through 1:30 p.m. EDT on May 10, 2018. The replay will also be available through View Source or by calling the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 4713257.

On April 26, 2018 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that it received an Import Medical Device Market Approval from the China Food and Drug Administration (CFDA) for CAN002 as a cancer adjuvant therapy, on April 2, 2018. CAN002, marketed as Caphosol in 47 countries, is an oral rinse for the treatment of oral mucositis, the inflammation and ulceration of the mucous membranes lining the mouth that occurs frequently in cancer patients undergoing high-dose chemotherapy, radiation and hematopoietic stem cell transplants (Press release, CANbridge Life Sciences, APR 26, 2018, View Source [SID1234525762]). CAN002 is CANbridge’s first commercialized product.

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In 2014, CANbridge entered into an exclusive partnership with EUSA Pharma for the right to commercialize Caphosol in China. EUSA Pharma is a specialty pharmaceutical company with a focus on oncology and oncology supportive care, with commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world.

"We are delighted with the approval by the CFDA of CAN002, which marks our transition into a commercial stage company," said James Xue PhD, Chairman and CEO, CANbridge Life Sciences. "There is currently no standard-of-care in China for this painful and often debilitating condition that affects so many patients undergoing cancer treatment, as well as those dealing with other diseases. We are particularly proud to be able to bring this proven treatment to patients in mainland China, as we continue in our mission to shorten the runway between Western approval and availability in China. With CAN030 (Nerlynx) queued up as the next product closest to market, we anticipate CANbridge’s accelerated growth as a commercial company."

About CAN002 (Caphosol)

Caphosol is a supersaturated calcium phosphate oral rinse solution to treat oral mucositis (OM)—inflammation and ulcers in the mouth— caused by radiation, high-dose chemotherapy, and bone-marrow transplants to treat blood cancers. Approved in 48 countries, it has demonstrated robust clinical efficacy in preventing and treating OM, and has an excellent safety profile. The incidence of oral mucositis varies across cancer patient populations. However, according to the Oncology Nursing Society, it affects almost all patients undergoing radiation therapy for head and neck cancers; 80% of patients under going a stem cell transplant to treat blood cancer; and nearly half (40%) of patients receiving standard chemotherapy.

On April 26, 2018 Idera Pharmaceuticals, Inc. (Idera) (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel oligonucleotide therapeutics for oncology and rare diseases, reported the acceptance of three abstracts related to the ILLUMINATE clinical development program at the upcoming ASCO (Free ASCO Whitepaper) meeting being held June 1-5, 2018 in Chicago (Press release, Idera Pharmaceuticals, APR 26, 2018, View Source [SID1234525720]). The abstracts include a clinical data update from the ILLUMINATE 204 trial in anti-PD-1 refractory melanoma provided by lead investigator Adi Diab, MD from the University of Texas MD Anderson Cancer Center; this abstract will also be featured in a poster discussion session at the meeting.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The company plans to hold an investor/analyst event at the ASCO (Free ASCO Whitepaper) Annual Meeting on Monday, June 4, 2018, which will feature a presentation by ILLUMINATE 204 lead investigator Adi Diab, MD as well as Q&A with attendees. As a convenience to those unable to attend in person, the event will be webcast. Full event details will be provided closer to the meeting.

Additionally, the Phase 3 ILLUMINATE 301 trial in anti-PD-1 refractory melanoma has opened to enrollment during the first quarter of 2018.

About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the US Food and Drug Administration (FDA) in 2017 for the treatment of PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from the checkpoint therapy. Intratumoral injections with tilsotolimod are designed to selectively enable the T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

About ILLUMINATE-204
The Illuminate 204 study (2125-204) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda (pembrolizumab) or Opdivo (nivolumab) has failed. Melanoma is the most dangerous type of skin cancer. When it is metastatic, it means that the melanoma has spread to different parts of the body. Illuminate 204 is a multi-center, two-arm Phase 1/2 study that tests the safety and effectiveness of tilsotolimod in combination with either ipilimumab (Yervoy) or pembrolizumab (Keytruda) for the treatment of patients with PD-1 refractory metastatic melanoma.

For additional details about Illuminate 204, please go to clinicaltrials.gov and search for study identifier NCT02644967.

About ILLUMINATE-301
The Illuminate 301 study (2125-MEL-301) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda (pembrolizumab) or Opdivo (nivolumab) has failed. Illuminate 301 is a multi-center, randomized Phase 3 study that compares the effectiveness and safety between two treatment groups: IMO-2125 combined with ipilimumab (Yervoy) versus ipilimumab given alone.

For additional details about Illuminate 301, please go to clinicaltrials.gov and search for study identifier NCT03445533.

About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers. Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths. The American Cancer Society estimates that there were approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease in the USA in 2016. Additionally, according to the World Health Organization, about 132,000 new cases of melanoma are diagnosed around the world every year.