On November 2, 2016 Bristol-Myers Squibb Company (NYSE:BMY) reported new data evaluating the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) and Opdivo plus new investigational Immuno-Oncology assets, including lirilumab, will be presented at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 31st Annual Meeting from November 9 – 11 in National Harbor, Maryland (Press release, Bristol-Myers Squibb, NOV 2, 2016, View Source [SID1234516183]). These presentations underscore Bristol-Myers Squibb’s dedication to investigating complementary Immuno-Oncology compounds that target different immune system pathways, including the ongoing study of Opdivo and Yervoy, with the goal of discovering transformational combinations that may offer the most significant improvements in overall survival and address areas of high unmet patient need.

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"We look forward to presenting new data at SITC (Free SITC Whitepaper) from our innovative Immuno-Oncology pipeline," said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. "Research has shown that targeting multiple immune system pathways may enhance anti-tumor responses, and there are a vast number of combinations to explore. We are committed to discovering novel pathways and complementary mechanisms that have the potential to significantly improve the standard of care in a broad range of tumor types."

Bristol-Myers Squibb is focused on developing transformational Immuno-Oncology combination therapies and expects to have 13 Immuno-Oncology compounds and seven targeted oncology compounds in the clinic by early 2017.

A listing of late-breaking and oral presentations is included below:

Late-Breaking Oral Presentations

Preliminary efficacy from a Phase 1/2 study of the natural killer cell–targeted antibody, lirilumab in combination with nivolumab in squamous cell carcinoma of the head and neck
Author: R. Leidner
Poster #456
Oral Late Breaking Abstract Session II
Saturday, November 12 at 11:15 – 11:30 am/EST
Efficacy and safety of nivolumab plus ipilimumab in metastatic urothelial carcinoma: First results from the Phase I/II CheckMate 32 Study
Author: P. Sharma
Poster #449
Oral Late Breaking Abstract Session II
Saturday, November 12 at 11:30 – 11:45 am/EST
Oral Presentations

Clinical safety and efficacy assessment of the CD137 agonist urelumab alone and in combination with nivolumab in patients with hematologic and solid tumor malignancies
Author: E. Massarelli
Poster #239
Oral Presentation: Beyond Single Agents: The Future of Combination Immunotherapies
Saturday, November 12 at 10:40 – 10:55 am/EST
The full set of data to be presented at SITC (Free SITC Whitepaper) by Bristol-Myers Squibb also includes:

Initial experience administering BMS-986016, a monoclonal antibody that targets lymphocyte activation gene (LAG)-3, alone and in combination with nivolumab to patients with hematologic and solid malignancies
Author: E. Lipson
Poster #238
Saturday, November 12 at 12 – 1 pm/EST
Enhanced vaccine-induced T-cell responses observed with ipilimumab (anti-CTLA-4) treatment in a nonhuman primate pharmacodynamic model
Author: J. Loffredo
Poster #102
Saturday, November 12 at 12 – 1 pm/EST
Assessing the potential for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) by combining the CD137 antibody urelumab with rituximab or cetuximab in patients with refractory lymphoma or select advanced solid tumors
Author: N. Segal
Poster #267
Friday, November 11 at 12:15 – 1:30 pm/EST
Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science & Innovation

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents – including the first combination of two I-O agents in metastatic melanoma – and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 12 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part, but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 57 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 47 countries, including the United States and the European Union.

U.S. FDA APPROVED INDICATIONS FOR OPDIVO

OPDIVO (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please refer to the end of the Important Safety Information for a brief description of the patient populations studied in the CheckMate trials.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Neuropathies

In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.

Immune-Mediated Skin Adverse Reactions and Dermatitis

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome.

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.

Complications of Allogeneic HSCT after OPDIVO

Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]).

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

CHECKMATE Trials and Patient Populations

CheckMate 067 – advanced melanoma alone or in combination with YERVOY; CheckMate 037 and 066 – advanced melanoma; CheckMate 017 – squamous non-small cell lung cancer (NSCLC); CheckMate 057 – non-squamous NSCLC; CheckMate 025 – renal cell carcinoma; CheckMate 205/039 – classical Hodgkin lymphoma.

Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, for YERVOY.

Please see U.S. Full Prescribing Information for OPDIVO.

On November 1, 2016 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of potentially curative therapeutics using CRISPR/Cas9 technology, reported results for the quarter ended September 30, 2016 and provided an update on recent highlights and upcoming events (Press release, Intellia Therapeutics, NOV 1, 2016, View Source;p=RssLanding&cat=news&id=2218160 [SID1234516144]).

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"We have demonstrated substantial progress in our research, including being the first company to present data showing high levels of in vivo editing in animal models using systemic lipid nanoparticles to deliver CRISPR/Cas9 components," said Nessan Bermingham, Ph.D., Chief Executive Officer and Founder, Intellia Therapeutics. "We continue to make further enhancements and remain focused on advancing the development of CRISPR/Cas9-based therapeutics for patients with severe unmet medical needs."

Recent Highlights

Intellia presented preclinical data demonstrating in vivo gene editing using lipid nanoparticles (LNPs) to deliver CRISPR/Cas9. These data were presented at the Genome Engineering: The CRISPR/Cas Revolution meeting in Cold Spring Harbor, New York. In several preclinical studies, the data showed:
Progress in achieving in vivo editing, reporting an efficiency of approximately 60 percent in mouse liver at the transthyretin (TTR) target site after a single intravenous administration, which was consistent across different lobes of the liver. This resulted in an associated decrease in serum TTR protein levels of up to approximately 80 percent;
Dose-dependent editing by LNP delivery;
Undetectable Cas9 mRNA and guide RNA (gRNA) in the liver at 72 hours post administration; and
Repair patterns in mouse liver cells in vivo being best predicted in vitro by primary mouse liver cells rather than cell lines.

Intellia presented four posters at the recent European Society for Gene and Cell Therapy Congress (ESGCT) in Florence, Italy. The data presentations included an update on the Company’s in vivo delivery and DNA repair data and new methods for analyzing off-target activity. In its presentation on off-target analysis, Intellia described improved computational methods for readily identifying guide RNAs with zero to few off-target events, an essential step in developing CRISPR/Cas9-based therapeutics.
Third Quarter 2016 Financial Results

As of September 30, 2016, Intellia had $290.6 million in cash and cash equivalents. Net loss for the third quarter 2016 was $7.5 million, compared to $3.0 million in the same period in 2015.

Collaboration revenue was $4.9 million in the third quarter 2016, compared to $1.7 million in the same period of 2015. For the Novartis collaboration, Intellia recognized $2.0 million and $1.7 million in the third quarters of 2016 and 2015, respectively. The Regeneron collaboration, announced in April 2016, for which the Company recognized $2.9 million in the third quarter of 2016, was the primary driver of the increase in collaboration revenue.

Research and development expenses in the third quarter 2016 were $7.9 million, compared to $3.5 million in the same period in 2015. This increase in expenses is primarily attributable to accelerating the development of our CRISPR/Cas9 platform and advancing our sentinel indications. These expenses include compensation and benefits for employees, including equity-based compensation, and expansion of Intellia’s facilities and laboratories.

General and administrative expenses were $4.7 million in the third quarter of 2016, compared to $1.5 million for the same period in 2015. The increase in general and administrative expenses is primarily driven by expenses to support the Company’s overall growth and costs associated with being a publicly traded company.

Upcoming Events

Intellia will present at the Fortune Brainstorm Health 2016 Conference in San Diego on November 2, 2016, the Credit Suisse Healthcare Conference in Arizona on November 7, 2016, and the Jefferies 2016 Healthcare Conference in London on November 16, 2016.

On November 1, 2016 Illumina, Inc. (NASDAQ:ILMN) reported its full financial results for the third quarter of fiscal year 2016 (Filing, Q3, Illumina, 2016, NOV 1, 2016, View Source [SID1234516299]).

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Third quarter 2016 results:
•
As previously announced on October 10, 2016, revenue of $607 million, a 10% increase compared to $550 million in the third quarter of 2015
•
GAAP net income attributable to Illumina stockholders for the quarter of $129 million, or $0.87 per diluted share, compared to $118 million, or $0.79 per diluted share, for the third quarter of 2015
•
Non-GAAP net income attributable to Illumina stockholders for the quarter of $144 million, or $0.97 per diluted share, compared to $120 million, or $0.80 per diluted share, for the third quarter of 2015 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
•
Cash flow from operations of $150 million and free cash flow of $93 million for the quarter, compared to $181 million and $152 million in the prior year period

Gross margin in the third quarter of 2016 was 70.2% compared to 70.4% in the prior year period. Excluding the effect of non-cash stock compensation expense and amortization of acquired intangible assets, non-GAAP gross margin was 72.5% for the third quarter of 2016 compared to 73.2% in the prior year period.

Research and development (R&D) expenses for the third quarter of 2016 were $125.9 million, or 20.7% of revenue, compared to $99.2 million, or 18.1% of revenue, in the prior year period. R&D expenses included $11.5 million and $9.1 million of non-cash stock compensation expense in the third quarters of 2016 and 2015, respectively. Excluding these charges and contingent compensation, R&D expenses as a percentage of revenue were 18.8%, including 2.4% attributable to GRAIL and Helix. This compares to 16.4% in the prior year period.

Selling, general and administrative (SG&A) expenses for the third quarter of 2016 were $139.1 million, or 22.9% of revenue, compared to $136.6 million, or 24.8% of revenue, in the prior year period. SG&A expenses included $20.0 million and $20.1 million of non-cash stock compensation expense in the third quarters of 2016 and 2015, respectively. Excluding these charges, amortization of acquired intangible assets, and contingent compensation, SG&A expenses as a percentage of revenue were 19.3%, including 1.5% attributable to GRAIL and Helix. This compares to 20.9% in the prior year period, including 0.9% attributable to Helix.

Depreciation and amortization expenses were $35.9 million and capital expenditures for free cash flow purposes were $57.1 million during the third quarter of 2016, which excludes an increase of $83.9 million in property and equipment recorded under build-to-suit lease accounting since such expenses were paid for by the landlord.

At the close of the quarter, the company held $1.54 billion in cash, cash equivalents and short-term investments, compared to $1.39 billion as of January 3, 2016.

"While sequencing sample volume growth remains robust, our lowered revenue outlook reflects our updated expectations for HiSeq 2500, HiSeq 4000 and HiSeq X instrument purchases, as well as HiSeq 2500 reagent sales," stated Francis deSouza, President and CEO. "Over the last few weeks it has become clear that certain academic funding practices were modified in the third quarter, limiting our customers’ ability to make HiSeq X capital commitments. Further, HiSeq 2500 and 4000 demand has been impacted by a migration to NextSeq, for enhanced workflow flexibility and HiSeq X, given its beneficial pricing for whole genome sequencing."

Updates since our last earnings release:
•
Announced a partnership with FlowJo, LLC to develop and co-market analysis software for single cell next-generation sequencing data
•
Received orders for an additional 2 million samples of the Infinium Global Screening Array, for a total of more than 5 million samples ordered to date
•
Appointed Philip W. Schiller to the company’s Board of Directors
•
Announced that Christian Henry, Executive Vice President and Chief Commercial Officer, will be leaving the company. Appointed Mark van Oene, currently Senior Vice President and General Manager, Americas, as Interim Chief Commercial Officer
•
Announced that Illumina’s Board of Directors has authorized the company to repurchase up to $250 million of outstanding common shares in the open market or in privately negotiated transactions, subject to market conditions and other factors. The company repurchased $13 million of common stock under this new stock authorization

Financial outlook and guidance
The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

The company continues to project fourth quarter revenue to be flat to slightly up compared to the third quarter. For fiscal 2016, non-GAAP earnings per diluted share attributable to Illumina stockholders is forecasted to be $3.27 to $3.32.

Quarterly conference call information
The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, November 1, 2016. Interested parties may listen to the call by dialing 888.771.4371 (passcode: 43579048), or if outside North America

by dialing +1.847.585.4405 (passcode: 43579048). Individuals may access the live teleconference in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on November 1, 2016 through November 8, 2016 by dialing 888.843.7419 (passcode: 43579048), or if outside North America by dialing +1.630.652.3042 (passcode: 43579048).

On November 1, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal first-quarter 2017, provided an update on recent business highlights, maintained its fiscal year 2017 financial guidance and issued fiscal second-quarter 2017 financial guidance (Press release, Myriad Genetics, NOV 1, 2016, View Source [SID1234516145]).

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"We were pleased with the first quarter as our hereditary cancer business returned to more normal volume trends, and we secured important endorsements from physician networks representing 70 percent of community oncologists in the United States," said Mark C. Capone, president and CEO of Myriad. "In addition, our newest tests, Genesight, EndoPredict, and Prolaris all exceeded 50 percent growth rates, and we successfully completed PARP inhibitor studies with the first prospective validation of myChoice HRD and an additional validation for BRACAnalysis CDx. We remain committed to transforming Myriad into a larger and more diversified personalized medicine company and delivering upon our five-year strategic goals."

Financial Highlights

Below are tables summarizing the financial results and revenue by product class for our fiscal first-quarter 2017:
Revenue
Fiscal First-Quarter

($ in millions) 2017 2016 % Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 139.3 $ 156.7 (11 %)

GeneSight testing revenue 7.2* 0.0 NM

Vectra DA testing revenue 11.6 11.4 2 %

Prolaris testing revenue 2.9 0.7 314 %

EndoPredict testing revenue 1.7 0.8 113 %

Other testing revenue 2.4 2.3 4 %

Total molecular diagnostic testing revenue 165.1 171.9 (4 %)

Pharmaceutical and clinical service revenue 12.4 11.6 7 %

Total Revenue $ 177.5 $ 183.5 (3 %)

Income Statement
Fiscal First-Quarter

($ in millions) 2017 2016 % Change
Total Revenue $ 177.5 $ 183.5 (3 %)

Gross Profit 137.5 147.0 (7 %)
Gross Margin 77.5 % 80.1 %

Operating Expenses 131.3 103.7 27 %

Operating Income 6.2 43.3 (86 %)
Operating Margin 3.5 % 23.6 %

Adjusted Operating Income 21.6 46.5 (54 %)
Adjusted Operating Margin 12.2 % 25.3 %

Net Income (1.2 ) 30.3 NM

Diluted EPS (0.02 ) 0.42 NM

Adjusted EPS $ 0.23 $ 0.41 (44 %)
* represents revenue for the month of September only

Business Highlights

myRisk Hereditary Cancer
Signed preferred provider agreements with major physician networks in oncology representing approximately 70 percent of community oncologists in the country, or approximately 4,000 physicians.
Launched a customizable myRisk panel for genetics experts who are interested in tailoring their gene selections.
Ended the quarter with 65 percent of revenue under long-term contract and 95 percent of insurance plans in network.

GeneSight
Volumes were up 70 percent year-over-year to approximately 51,000 tests performed in the full fiscal first-quarter 2017.
Reached 90 percent enrollment in a landmark 1,200 patient clinical utility study evaluating GeneSight in patients with depression or anxiety treated by preventive care physicians or psychiatrists.

Vectra DA
Volumes were up four percent year-over-year in the fiscal first-quarter with approximately 39,000 tests performed.
Announced the presentation of four abstracts at the American College of Rheumatology conference in November, showing the ability of Vectra DA to predict which patients will experience flare or sustained remission, and the ability of the Vectra DA score to provide added predictive value to traditional measures of disease activity.

Prolaris
Volumes increased 56 percent year-over-year with approximately 4,400 tests ordered.

Companion Diagnostics
Announced data from the first prospective validation of myChoice HRD from the NOVA study, evaluating the PARP inhibitor, niraparib. In the study, which evaluated platinum-sensitive ovarian cancer patients, myChoice HRD positive patients demonstrated a 9.1 month median progression free survival benefit versus a 3.1 progression free survival benefit in myChoice HRD negative patients. Myriad has submitted the first module of its premarket approval application for myChoice HRD to the FDA.
Announced data from the AstraZeneca SOLO2 study, which compared maintenance olaparib against placebo in patients with platinum-sensitive relapsed ovarian cancer met its primary endpoint. These results further validate that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.
Myriad signed an agreement with AstraZeneca to use its newest companion diagnostic, myChoice HRD Plus, to help prospectively identify patients for enrollment in an upcoming exploratory study involving olaparib. myChoice HRD Plus combines Myriad’s proprietary myChoice HRD assay with 102 additional genes involved in DNA repair.

International
Revenues were up 43 percent year-over-year in the first quarter and accounted for approximately five percent of total product revenue.
EndoPredict revenues grew 113 percent year-over-year to $1.7 million in the first quarter of fiscal year 2017.
Completed enrollment in an EndoPredict study evaluating the ability of the test to predict response to neoadjuvant chemotherapy. Results of the study are expected to be presented in calendar year 2017.
In August, the German public reimbursement system (GBA) issued new ambulatory specialty care (ASV) reimbursement covering gene expression testing for breast cancer when conducted in authorized major centers throughout Germany.

Share Repurchase
During the quarter, the Company repurchased approximately 1.0 million shares, or $21 million, of common stock under our share repurchase program and ended the quarter with approximately $171 million remaining on our current share repurchase authorization.
Fiscal Year 2017 and Fiscal Second-Quarter 2017 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2017 and fiscal second-quarter 2017 financial guidance:

Revenue Adjusted Earnings Per Share GAAP Diluted Earnings Per Share
Fiscal Year 2017 $740-$760 million $1.00-$1.10 $0.34-$0.44

Fiscal Second-Quarter 2017 $188-$190 million $0.23-$0.25 $0.06-$0.08

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during its conference call today to discuss the fiscal first-quarter financial results and fiscal year 2017 and fiscal second-quarter 2017 financial guidance.

On November 1, 2016 QLT Inc. (NASDAQ:QLTI) (TSX:QLT) ("QLT" or the "Company") reported financial results for the third quarter ended September 30, 2016. Unless otherwise specified, all amounts are reported in U.S. dollars and in accordance with U.S. GAAP (Press release, QLT, NOV 1, 2016, View Source;p=RssLanding&cat=news&id=2217788 [SID1234516148]).

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2016 THIRD QUARTER FINANCIAL RESULTS

Operating Expenses/Income

During the third quarter of 2016, research and development ("R&D") expenditures were $2.9 million compared to $2.1 million for the same period in 2015. The $0.8 million (38%) increase was primarily due to higher costs related to preparatory activities for our upcoming Phase III pivotal trial for QLT091001.

During the third quarter of 2016, we incurred $1.9 million of consulting and advisory fees on activities to support our pending merger transaction with Aegerion Pharmaceuticals, Inc. ("Aegerion"), which is described below. In comparison, we incurred $2.2 million of similar costs in 2015 related to: (i) the pursuit of our merger transaction with InSite Vision Incorporated ("InSite"), which was terminated by InSite on September 15, 2015, and (ii) activities to support our investment in Aralez Pharmaceuticals, Inc. ("Aralez"), which was subsequently distributed to our shareholders on April 5, 2016 (the "Aralez Distribution").

Excluding the strategic consulting and advisory fees described above, selling, general and administrative ("SG&A") expenditures for the third quarter of 2016 were relatively consistent with SG&A expenditures incurred during the same period in 2015.

Operating Loss and Net Loss per Share

The operating loss for the third quarter of 2016 was $6.0 million, compared to $2.8 million for the same period in 2015. The net $3.2 million change in our operating loss was primarily due to a $2.7 million non-recurring termination fee received from InSite in September 2015, in connection with InSite’s termination of the merger agreement, as well as higher R&D costs in the third quarter of 2016 associated with preparatory activities for our upcoming Phase III pivotal trial for QLT091001.

Net loss per common share was $0.11 in the third quarter of 2016, compared to $0.05 for the same quarter in 2015. The change in our net loss per common share was primarily due to the same factors described above.

Cash and Cash Equivalents

As at September 30, 2016, the Company’s consolidated cash and cash equivalents were $73.1 million compared to $141.8 million at December 31, 2015. The $68.7 million decrease was primarily due to: (i) the $45.0 million investment in Aralez and subsequent Aralez Distribution (as described above), (ii) $9.2 million of strategic consulting and advisory fees related to the proposed merger with Aegerion, the Aralez Distribution, and the exploration of other strategic alternatives, (iii) $3.0 million advanced to Aegerion pursuant to the terms of the interim loan agreement with Aegerion, and (iv) cash used in operating activities during the period.

AEGERION MERGER TRANSACTION UPDATE

As previously announced, on June 14, 2016, Aegerion and QLT agreed to a merger (the "Merger") under the terms of an Agreement and Plan of Merger by and among Aegerion, QLT and Isotope Acquisition Corp., an indirect wholly-owned subsidiary of QLT. While the proposed Merger has been approved by the boards of directors of both companies, the closing of the Merger is subject to various conditions, including but not limited to (i) receipt of the required approvals of the shareholders at the special meetings of each QLT and Aegerion on November 7, 2016, and (ii) completion of the $21.8 million QLT private placement contemplated by the unit subscription agreement entered into with certain investors in connection with the Merger. The Merger is expected to close in the fourth quarter of 2016.

SYNTHETIC RETINOID UPDATE

The Company continues its Phase III pivotal trial start-up activities to test the safety and efficacy of its Fast Track and Orphan Drug Designated investigational drug product, QLT091001 in subjects with Inherited Retinal Disease phenotypically diagnosed as LCA or RP caused by RPE65 or LRAT gene mutations, with a goal of initiating the pivotal trial in the fourth quarter of 2016.

In addition to the Fast Track and Orphan Drug Designations previously granted to us by the FDA for QLT091001, the Company is currently exploring the potential of submitting to the FDA a request for a Rare Pediatric Disease Designation of QLT091001. Under the Federal Food, Drug, and Cosmetic Act, a sponsor who receives an approval of a New Drug Application (NDA) for a Rare Pediatric Disease and meets certain additional criteria, may be eligible to be awarded a Rare Pediatric Disease Priority Review Voucher (PRV). A PRV can be redeemed to receive a priority review for any subsequent marketing application for a different product. A PRV, if obtained by a sponsor, may be sold or transferred to another sponsor. The FDA’s authority to award Rare Pediatric Disease PRVs is currently set to expire December 31, 2016. The authority has been extended multiple times previously, and while it is possible that it may be further extended or made permanent in the future, there is no guarantee of any such extension.

In addition, U.S. Patent No. 9,403,765 relating to various methods of use of various synthetic retinal esters, including QLT091001, for the treatment of diseases associated with an endogenous 11-cis-retinal deficiency, including LCA and RP, was granted by the USPTO on August 2, 2016. This patent is currently projected to expire on June 20, 2025. This newly issued patent further enhances the Company’s key patent portfolio around methods of using QLT091001 in the treatment of IRD.

Passive Foreign Investment Company

The Company believes that it was classified as a Passive Foreign Investment Company ("PFIC") for 2008 through 2015, and that it may be classified as a PFIC in 2016, which could have adverse tax consequences for U.S. shareholders. Please refer to our 2015 Annual Report on Form 10-K (as amended by the Form 10-K/A filed on April 29, 2016) for additional information.

QLT Inc. – Financial Highlights
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands of U.S. dollars except share and per share information)
Three months ended Nine months ended
September 30, September 30,
2016 2015 2016 2015

Expenses
Research and development $ 2,855 $ 2,142 $ 8,774 $ 7,754
Selling, general and administrative 3,138 3,166 13,487 13,939
Depreciation 24 141 85 508
Termination fee – (2,667 ) – (2,667 )
6,017 2,782 22,346 19,534
Operating loss (6,017 ) (2,782 ) (22,346 ) (19,534 )
Other (expense) income
Net foreign exchange losses (105 ) (43 ) (214 ) (5 )
Interest income 110 152 240 235
Fair value loss on investment – - (10,704 ) -
Other (39 ) (6 ) (30 ) (8 )
(34 ) 103 (10,708 ) 222
Loss before income taxes (6,051 ) (2,679 ) (33,054 ) (19,312 )
Recovery of (Provision for) income taxes 115 (3 ) 104 (17 )
Net loss and comprehensive loss $ (5,936 ) $ (2,682 ) $ (32,950 ) $ (19,329 )

Basic and diluted net loss per common share
Net loss per common share $ (0.11 ) $ (0.05 ) $ (0.62 ) $ (0.37 )

Weighted average number of common shares outstanding (thousands)
Basic and diluted 52,829 52,829 52,829 51,949

CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands of U.S. dollars) September 30, 2016 December 31, 2015
ASSETS
Current assets
Cash and cash equivalents $ 73,056 $ 141,824
Accounts receivable, net of allowances for doubtful accounts 186 287
Loan receivable 3,073 -
Income taxes receivable 14 14
Prepaid and other assets 450 611
Total current assets 76,779 142,736
Accounts receivable 2,000 2,000
Property, plant and equipment 270 430
Total assets $ 79,049 $ 145,166
LIABILITIES
Current liabilities
Accounts payable $ 3,308 $ 1,656
Accrued liabilities 1,058 1,827
Total current liabilities 4,366 3,483
Uncertain tax position liabilities - 342
Total liabilities 4,366 3,825
SHAREHOLDERS’ EQUITY
Share capital
Authorized
500,000,000 common shares without par value
5,000,000 first preference shares without par value, issuable in series
Issued and outstanding common shares $ 475,333 $ 475,333
September 30, 2016 – 52,829,398 shares
December 31, 2015 – 52,829,398 shares
Additional paid-in capital 63,669 97,377
Accumulated deficit (567,288 ) (534,338 )
Accumulated other comprehensive income 102,969 102,969
Total shareholders’ equity 74,683 141,341
Total shareholders’ equity and liabilities $ 79,049 $ 145,166