On February 25, 2019 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported its financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Alder Biopharmaceuticals, FEB 25, 2019, View Source [SID1234533649]). Alder also noted that it announced the completion of its Biologics License Application (BLA) submission for eptinezumab, the company’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide and lead commercial candidate, with the Food and Drug Administration (FDA) on February 22, 2019.

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r Alder, capped by the completion of eptinezumab’s BLA submission to the FDA last week," said Bob Azelby, president and chief executive officer of Alder. "We achieved all of the significant milestones we targeted for the year including positive top-line data from our PROMISE 2 Phase 3 clinical trial and positive PROMISE 1 and PROMISE 2 Phase 3 data demonstrating sustained or increased migraine prevention following subsequent infusions, as well as positive results from a pharmacokinetic study, to name a few. The achievement of these milestones further demonstrates eptinezumab’s differentiated profile, which we believe will allow Alder to compete in the highly impacted migraine patient segment."

Mr. Azelby added, "As we look ahead to 2019, we continue to make substantial progress advancing our supply chain, building commercial inventory, expanding our commercial and operational infrastructure, and executing on key pre-launch initiatives to enable a successful commercial launch of eptinezumab in the first quarter of 2020, if approved. Additionally, consistent with our commitment to forever change migraine treatment and give patients their lives back, we are focused on advancing our pre-clinical candidate, ALD1910. The totality of our pre-clinical data to date gives us confidence that we will be positioned to initiate a first in-human clinical trial by the end of 2019."

2019 Highlights and Upcoming Milestones

On February 22, Alder announced it completed its BLA submission for eptinezumab with the FDA. The BLA submission was supported by positive results from Alder’s two positive Phase 3 trials of eptinezumab, positive results from an open-label safety study and a pharmacokinetic (PK) comparability study, and chemistry, manufacturing, and controls (CMC) data packages.

Alder remains on track for the potential commercial launch of eptinezumab in the first quarter of 2020, and continues to advance its manufacturing and commercial readiness activities in anticipation of launch. Currently, Alder is advancing its supply chain, building commercial inventory, continuing to build out its commercial and operational infrastructure, and executing against other key pre-launch initiatives.

Alder continues to advance its pre-clinical candidate, ALD1910, a monoclonal antibody targeting PACAP-38 (pituitary adenylate cyclase-activating peptide-38). ALD1910 is currently undergoing Investigational New Drug (IND)-enabling preclinical studies and Alder expects to initiate its first in-human clinical study by the end of 2019.

In January, Alder announced the appointment of Dr. Paul Streck as Chief Medical Officer. He brings more than 25 years of experience in drug development, regulatory and medical affairs leadership across both large and small publicly traded biopharmaceutical companies. Dr. Streck previously served as Chief Medical Officer at Insmed Incorporated, where he played an instrumental role as a member of the executive leadership team and successfully led the Arikayce regulatory filing, approval and launch.

2018 Company Milestones

In December, Alder announced the appointment of Carlos Campoy as Chief Financial Officer. He brings nearly 30 years of financial leadership and expertise across global publicly-traded companies, including more than 20 years in the biopharmaceutical and healthcare sectors. Mr. Campoy previously served as Vice President of Finance, International at Allergan plc, where he had financial responsibility for $3B in sales and drove significant growth across all product divisions, including Neurosciences and BOTOXÒ.

In October, Alder announced positive results from a comparative PK study that supported the comparability evaluation of the clinical supply for eptinezumab and its planned commercial supply. Both the primary and key secondary PK results met the standard pre-specified acceptance criteria for drug product comparability.

In June, new data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials for eptinezumab in episodic and chronic migraine patients, respectively, were presented at the American Headache Society Meeting. The new data highlighted the strength of eptinezumab’s efficacy data by showing sustained or increased efficacy following subsequent quarterly administrations of eptinezumab.

In April, new data from Alder’s PROMISE 1 Phase 3 clinical trial for eptinezumab in episodic migraine patients were presented at the 70th Annual AAN Meeting. The new data demonstrated long-term and sustained or further increased efficacy in episodic migraine following the third and fourth quarterly infusion, as well as increased migraine-free intervals and improved quality of life outcomes.

Also in the second quarter of 2018, Alder completed a one-year safety study of eptinezumab, which generated favorable safety and tolerability data and demonstrated a favorable safety profile consistent with previous eptinezumab studies.

In January, Alder announced eptinezumab significantly reduced migraine risk and met the primary and all key secondary endpoints in its pivotal PROMISE 2 Phase 3 clinical trial for chronic migraine prevention.

Also in January 2018, Alder entered into a settlement and global license agreement with Teva Pharmaceuticals International GmbH, which provided clarity regarding Alder’s freedom to develop, manufacture and commercialize eptinezumab in the U.S. and globally.

Fourth Quarter and Year-End 2018 Financial Results

As of December 31, 2018, Alder had $412.4 million in cash and cash equivalents, short-term investments and restricted cash, compared to $484.7 million as of Sept. 30, 2018 and compared to $286.2 million as of December 31, 2017.

Research and development expenses for the fourth quarter ended December 31, 2018 totaled $64.4 million, compared to $44.7 million for the same period in 2017. For the full year 2018, research and development expenses totaled $239.1 million, compared to $252.9 million for the full year 2017. The year-over-year decrease was primarily due to lower clinical trial costs in 2018 as a result of the completion of several clinical trials.

General and administrative expenses for the fourth quarter ended December 31, 2018 totaled $13.0 million, compared to $10.3 million for the same period in 2017. For the full year 2018, general and administrative expenses totaled $47.5 million, compared to $38.1 million for the full year 2017. The year-over-year increases reflect Alder’s continued commitment to advance the eptinezumab program and position Alder for commercialization.

Net loss applicable to common stockholders for the fourth quarter ended December 31, 2018 totaled $81.5 million, or $1.19 per share, compared to net loss of $54.4 million, or $0.80 per share on a fully-diluted basis, for the same period in 2017. For the full year 2018, net loss applicable to common stockholders totaled $331.9 million, or $4.87 per share on a fully-diluted basis, compared to net loss of $288.9 million, or $4.95 per share, for the full year 2017.

Financial Outlook

Alder expects full-year 2019 net cash used in operating activities and purchases of property and equipment will be in the range of $285 to $315 million dollars. The majority of the spend is focused on ensuring that Alder is prepared for the potential launch of eptinezumab in the first quarter of 2020, including advancing eptinezumab’s supply chain, building commercial inventory, continuing to build out Alder’s commercial footprint and other pre-launch market readiness activities.

Alder believes its available cash, cash equivalents, short-term investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020 and the anticipated launch of eptinezumab.

Conference Call and Webcast

Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers and providing conference ID number 7655239. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for at least 30 days.

On February 25, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its financial results for the quarter- and year-ended December 31, 2018 (Press release, Corcept Therapeutics, FEB 25, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-1 [SID1234533647]).

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Financial Highlights

2018 revenue of $251.2 million, an increase of 58 percent from 2017
Fourth quarter revenue of $66.8 million, an increase of 25 percent from fourth quarter 2017
2018 GAAP net income of $0.60 per share, compared to $1.04 per share in 2017 (2017 includes one-time, non-cash tax benefit of $0.61 per share)
Fourth quarter GAAP net income of $0.18 per share, compared to $0.77 per share in fourth quarter 2017 (including $0.60 per share tax benefit)
Fourth quarter repurchases of 1.1 million shares of common stock; 2018 repurchases
totalling 1.8 million shares
Cash and investments at December 31, 2018 of $206.8 million, compared to $104.0 million
at December 31, 2017
Reiterated 2019 revenue guidance of $285 – 315 million
Relacorilant Phase 2 Trial Positive Top-Line Results

Relacorilant’s Phase 2 trial enrolled 35 patients, each of whom received a daily dose of relacorilant that was increased in 50 mg increments, as tolerable, every four weeks. The first 17 patients to enroll (the "low-dose cohort") started at 100 mg per day. The next 18 patients (the "high dose cohort") started at 250 mg per day.

Applying the endpoints for clinical benefit from relacorilant’s Phase 3 trial ("GRACE") to the high-dose cohort produces the following results:

Fifty percent of patients with hyperglycemia achieved improved glucose control, as shown by (i) a 0.5 percent or greater reduction in HbA1c or (ii) normalization of 2-hour oGTT glucose or decreased by at least 50 mg/dL or (iii) a 25 percent or greater decrease in antidiabetic medications
Sixty-four percent of patients with uncontrolled hypertension achieved a five millimeter or greater drop in either systolic or diastolic blood pressure, as measured by 24-hour ambulatory monitoring
No evidence of progesterone receptor affinity or hypokalemia
Plan to present data at the American Association of Clinical Endocrinologist ("AACE") Annual Scientific and Clinical Conference in Los Angeles, California, April 24-28th
Oncologic & Metabolic Disorders

Placebo-controlled, Phase 2 trial of relacorilant plus Abraxane in metastatic ovarian cancer underway, with planned enrollment of 180 patients in the United States and Europe
Data from dose-finding trial of relacorilant plus Abraxane to treat patients with metastatic, pancreatic cancer expected in second quarter
Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi to treat patients with metastatic castration-resistant prostate cancer
Placebo-controlled trial of CORT118335 for prevention of antipsychotic-induced weight gain to start second quarter; two trials in the reversal of antipsychotic-induced weight gain to start in second half of the year
Placebo-controlled, Phase 2 trial of CORT118335 to treat non-alcoholic steatohepatitis ("NASH") to start in second half of the year
Financial Results

Corcept’s 2018 revenue was $251.2 million, compared to $159.2 million in 2017. Fourth quarter revenue was $66.8 million, compared to $53.3 million in the fourth quarter of 2017. The company reiterated its 2019 revenue guidance of $285 – 315 million.

GAAP net income was $75.4 million for the year and $22.0 million in the fourth quarter of 2018, compared to $129.1 million for the year and $98.3 million in the fourth quarter of 2017. Fourth quarter 2017 net income included a one-time, non-cash gain of $76.4 million from the recognition of deferred tax assets.

Excluding non-cash tax benefits, non-cash expenses related to stock-based compensation, accreted interest on the company’s now-retired royalty financing obligation and related tax effects, non-GAAP net income was $30.4 in the fourth quarter, compared to $24.7 million in the fourth quarter of 2017. For the full-year, non-GAAP net income was $108.2 million, compared to $63.3 million in 2017. A reconciliation of GAAP to non-GAAP net income is included below.

Cash and investments increased by $10.1 million in the fourth quarter, to $206.8 million. This increase was after the expenditure of $14.8 million to acquire 1.1 million shares of the company’s common stock pursuant to its stock repurchase program. Under the program’s current terms, $76.3 million remains available for the repurchase of shares.

"2018 saw increased use of Korlym by patients with Cushing’s syndrome in every region of the country," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "In the fourth quarter, 583 physicians were treating patients with the medication – a number that we expect to grow. Increased Korlym uptake fueled our strong financial results: revenue increased by $92.0 million, non-GAAP net income increased by $45.0 million. Cash and investments nearly doubled to $206.8 million. In addition, we repurchased 1.8 million shares of our common stock.

"We continue to protect and extend our Cushing’s syndrome franchise. On February 5th, for example, we were issued a patent (U.S. Pat. No. 10,195,214) covering the co-administration of Korlym and strong CYP3A4 inhibitors – a class of drugs that includes powerful antiviral, antibiotic, antifungal and antidepressant medications. The scientific discoveries that gave rise to this patent constituted an important advance in the safe treatment of patients taking Korlym, which is why corresponding instructions to prescribers are included in Korlym’s label.

"In 2018, we also made important clinical advances in our Cushing’s syndrome program. Data from the Phase 2 trial of our candidate to succeed Korlym – the proprietary, selective cortisol modulator, relacorilant – were strongly positive, with many patients exhibiting meaningful clinical benefit. Just as important, there were no instances of the two off-target effects – progesterone receptor affinity and increased cortisol levels – that cause Korlym’s most common and serious adverse events – termination of pregnancy, endometrial thickening, vaginal bleeding and low potassium (hypokalemia). We immediately began relacorilant’s Phase 3 trial."

Relacorilant Phase 2 Data

Applying the endpoints for clinical benefit from relacorilant’s Phase 3 trial, 50 percent of patients with hyperglycemia in the high-dose cohort achieved improved glucose control (see Figure 1). The response rate in patients with hypertension was 64 percent (see Figure 2). These response rates are comparable to those exhibited by patients at 16 weeks and a dose of 1200 mg in Korlym’s pivotal trial ("SEISMIC").

Patients in the high-dose group also met a wide range of secondary endpoints, including statistically significant improvements in hypercoagulopathy, liver function, insulin resistance, cognition and mood.

Figure 1 Figure 2.
Figure 1. Patients achieving clinically meaningful reductions in HbA1c, 2-hour oGTT or use of antidiabetic medications. Figure 2. Patients achieving clinically meaningful improvements in hypertension.
Relacorilant was well-tolerated. The most commonly reported adverse events were backpain, peripheral edema, headache and nausea – adverse events that are frequently seen when excess cortisol activity is reduced and that tend to be transitory.

Relacorilant’s Phase 3 GRACE trial is underway. It is expected to enroll 130 patients at 60 sites in the United States, Canada, Europe and Israel.

Oncology & Metabolic Disease

"We expect our oncology and metabolic disease programs to take important steps forward in 2019," said Dr. Belanoff. "Following encouraging data from our Phase 1/2 dose-finding study, we have begun a 180 patient, controlled Phase 2 trial of relacorilant plus Abraxane to treat patients with metastatic ovarian cancer, a disease with few good treatment options. We continue to gather data in metastatic pancreatic cancer and plan to release our results and clinical development plan at the time of the ASCO (Free ASCO Whitepaper) meeting this June. We expect to select the optimal dose of CORT125281 plus Xtandi to treat patients with metastatic castration-resistant prostate cancer this year."

"We are excited to advance CORT118335 as a potential treatment for antipsychotic-induced weight gain and NASH," added Dr. Belanoff. "We plan three placebo-controlled trials in antipsychotic-induced weight gain: the first will investigate CORT118335’s ability to prevent weight gain in healthy subjects given olanzapine (Eli Lily’s Zyprexa). We plan to start this trial in the second quarter. The second two trials will be in patients taking antipsychotic medications – one to study the reversal of recently-established weight gain and the other to study the reversal of long-standing weight gain. They are planned to start in the second half of the year. Our placebo-controlled, Phase 2 trial of CORT118335 as a treatment for NASH is also planned for the second half of 2019."

Conference Call

We will hold a conference call on February 25, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-888-220-8451 from the United States or 1-323-794-2588 internationally approximately 10 minutes before the start of the call. The passcode is 6598298. A replay will be available through March 11, 2019 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 6598298.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

On February 25, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported that the Company plans to release its fourth quarter and fiscal year 2018 financial results on Wednesday, March 6, 2019 after the market closes (Press release, China Biologic Products, FEB 25, 2019, View Source [SID1234533644]).

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The Company’s management will hold a conference call at 7:30 a.m. ET on Thursday, March 7, 2019, which is 8:30 p.m. Beijing Time on March 7, 2019, to discuss fourth quarter and fiscal year 2018 results. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905945

China:

4001 201203

A telephone replay will be available one hour after the conclusion of the conference call through March 14, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10129171

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

On February 25, 2019 Taiho Oncology, Inc. reported that the United States Food and Drug Administration (FDA)reported that it has approved LONSURF as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy (Press release, Taiho, FEB 25, 2019, View Source [SID1234533643]).

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"The approval of LONSURF represents a significant milestone for patients living with advanced gastric or GEJ adenocarcinoma who have limited effective treatment options after standard treatment options have failed," said Timothy Whitten, President and Chief Executive Officer, Taiho Oncology, Inc. "We thank all the patients and physicians who helped make this possible through their participation in LONSURF clinical trials."

The approval for LONSURF follows an FDA Priority Review designation and is based on data from a global, randomized, Phase III TAGS trial evaluating LONSURF plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated advanced gastric cancer or GEJ adenocarcinoma following progression or intolerance to previous lines of standard therapy. The trial met its primary and secondary endpoints demonstrating prolonged overall survival (OS) with LONSURF versus placebo, and a safety profile consistent with prior experience with this drug. Full results from the TAGS trial were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress with a simultaneous publication in The Lancet Oncology.1

"Effective treatments for patients with heavily pretreated advanced gastric and GEJ cancer are limited," said Martin Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "By improving survival, LONSURF may provide a significant impact on the lives of these patients."

This approval expands the current indication for LONSURF in the United States, where it is currently approved for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with standard chemotherapy, based on results obtained in the RECOURSE trial.2,3

About TAGS
TAGS (TAS-102 Gastric Study) is a Taiho-sponsored, global, randomized, double-blind Phase III study evaluating trifluridine/tipiracil (TAS-102) plus BSC versus placebo plus BSC in patients with metastatic gastric or GEJ cancer, refractory to standard treatments. The primary endpoint in the TAGS trial was OS, and the main secondary endpoint measures included progression-free survival (PFS), safety and tolerability, as well as quality of life. The study enrolled 507 adult patients with metastatic gastric or GEJ cancer who had previously received at least two prior regimens for advanced disease and was conducted in 17 countries and 110 sites around the world.

For more information on TAGS, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT02500043.

About RECOURSE
The RECOURSE trial was a global, randomized, double-blind, placebo-controlled Phase III comparison trial evaluating the efficacy and safety of orally administered TAS-102 in patients with previously treated mCRC. The trial enrolled 800 patients in North America, Japan, Europe and Australia. Patients were randomized (2:1) to receive TAS-102 (35 mg/m2) or placebo, plus best supportive care, twice daily. The study met its primary and secondary endpoints of OS and PFS versus placebo.

About Gastric Cancer
Gastric cancer is the fifteenth most commonly diagnosed cancer in the United States (U.S.).4 In 2018, there were an estimated 26,240 new cases and 10,800 deaths in the U.S.4 Approximately 35 percent of U.S. patients with gastric cancer are diagnosed at the distant or metastasized stage.4 Metastatic gastric cancer (mGC) is associated with a five-year survival rate of about 5 percent.4

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. After failure of first- and second-line therapies, subsequent treatment options are limited.

About LONSURF2
LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

In Japan, Taiho Pharmaceutical Co., Ltd. has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, has been marketing LONSURF in the United States for metastatic CRC refractory to prior therapy, since receiving FDA approval in 2015. Taiho Pharmaceutical and Servier* are in an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia.

As of February 2019, LONSURF has been approved as a treatment option for advanced mCRC in 66 countries and regions worldwide.

*Servier is an international pharmaceutical company governed by a non-profit foundation, headquartered in France (Suresnes).

Important Safety Information

WARNINGS AND PRECAUTIONS

Severe Myelosuppression:

LONSURF caused severe and life‑threatening myelosuppression (Grade 3‑4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3%). Two patients (0.2%) died due to neutropenic infection. A total of 12% of LONSURF‑treated patients received granulocyte‑colony stimulating factors. Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, absolute neutrophil count less than 500/mm3, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.

Embryo‑Fetal Toxicity:

LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the final dose.

USE IN SPECIFIC POPULATIONS

Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast‑fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast‑fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.

Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.

Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anemia (22% vs 16%), and Grade 3 or 4 thrombocytopenia (7% vs 4%).

Hepatic Impairment: Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment.

Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Patients with severe renal impairment (CLcr < 30 mL/min) were not studied.

ADVERSE REACTIONS

Most Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF‑treated patients vs placebo‑treated patients with mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), infections (27% vs 16%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%). In metastatic gastric cancer or gastroesophageal junction (GEJ), the most common adverse drug reactions, respectively were, nausea (37% vs 32%), decreased appetite (34 vs 31%), vomiting (25% vs 20%), infections (23% vs 16%) and diarrhea (23% vs 14%).

Pulmonary emboli occurred more frequently in LONSURF‑treated patients compared to placebo: (2% vs 0%) in mCRC and (3% vs 2%) in metastatic Gastric Cancer and GEJ.

Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.

Laboratory Test Abnormalities in Patients Treated With LONSURF: Laboratory test abnormalities in LONSURF‑treated patients vs placebo-treated patients with mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%). In metastatic Gastric Cancer or GEJ, the test abnormalities, respectively, were neutropenia (66% vs 4%), anemia (63% vs 38%), and thrombocytopenia (34% vs 9%).

Please see full Prescribing Information.
View Source

Indications and Use2
LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

On February 25, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported that it will webcast an analyst and investor conference call with lead investigator of the REVEAL study, Dr. Adi Diab, and company management on Friday, March 1, 2019 at 3:00 p.m. Pacific Time during the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium (Press release, Nektar Therapeutics, FEB 25, 2019, https://www.prnewswire.com/news-releases/nektar-therapeutics-to-webcast-conference-call-for-analysts-and-investors-at-the-2019-asco-sitc-clinical-immuno-oncology-symposium-300801596.html [SID1234533642]). The event will follow Friday’s oral presentation by Dr. Diab of preliminary data from the ongoing dose-escalation stage of the REVEAL Phase 1/2 clinical study evaluating the combination of TLR agonist, NKTR-262, with a CD122-preferential IL-2 pathway agonist, bempegaldesleukin* (NKTR-214), in patients with locally advanced or metastatic solid tumors.

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Details on the Analyst Call:

Date and Time: Friday, March 1, 2019 at 3:00 p.m. Pacific Time

Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (international)

Passcode: 6970019

The conference call will include lead investigator on the REVEAL study, Dr. Adi Diab, Assistant Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center. The webcast and slides for the conference call can be accessed through a link that is posted on the Investors section of the Nektar website at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

Details on the Oral Presentation at ASCO (Free ASCO Whitepaper)-SITC:

Abstract Title: "Phase Ib: Preliminary clinical activity and immune activation for NKTR-262 [TLR 7/8

agonist] plus NKTR-214 [CD122-biased agonist] in patients (pts) with locally advanced or metastatic solid

tumors (REVEAL Phase Ib/II Trial)"

Abstract: #28

Presenter: Dr. Adi Diab, MD Anderson Cancer Center

Session: Oral Abstract Session B

Date and Time: Friday, March 1, 2019, 1:00 p.m.-2:15 p.m. Pacific Time