On May 7, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported first quarter 2019 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 7, 2019, View Source;p=RssLanding&cat=news&id=2397573 [SID1234535881]).

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"We have made great progress in recent months in advancing TIL therapy toward commercialization. In April, we dosed the first patient in the pivotal study, Cohort 4 of the innovaTIL-01 melanoma trial, bringing us a step closer to our goal of filing for regulatory approval of lifileucel in 2020," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We are pleased that three Iovance abstracts submitted to ASCO (Free ASCO Whitepaper) have been accepted, two of which include data updates from our fully enrolled Cohort 2 of our melanoma program and data from our ongoing LN-145 cervical study being presented for the first time in a medical conference at the 2019 meeting."

Recent Achievements and Upcoming Milestones

Clinical

In April 2019, the company announced that the first patient was dosed in Cohort 4 of the pivotal innovaTIL-01 study of lifileucel in metastatic melanoma.
New interim data from Cohort 2 of the innovaTIL-01 melanoma study and data from the ongoing innovaTIL-04 cervical cancer study will be presented on June 1, 2019 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
The company closed the IOV-LUN-201 study and instead will add an additional arm to the IOV-COM-202 study, adapting clinical development plans to reflect advances in the treatment landscape for non-small cell lung cancer.
The protocol for innovaTIL-04, the Phase 2 study in cervical cancer, was amended to increase the sample size to 59 and to modify the primary endpoint of Objective Response Rate (ORR) to be determined by a Blinded Independent Review Committee (BIRC). The company made the changes in anticipation of a meeting with the U.S. Food and Drug Administration (FDA) planned for later this year to discuss the registration pathway for LN-145 in cervical cancer.
Regulatory

In February 2019, LN-145 received Fast Track designation from the FDA for the cervical cancer indication.
Research

In April 2019, persistence and biomarker data from Cohort 2 of the innovaTIL-01 study of lifileucel in the treatment of advanced melanoma were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The presentation described results of an analysis of circulating T cells at 42 days post-infusion, highlighting the uniqueness of clonal profiles in TIL therapy in melanoma. The results support potential use of a polyclonal product such as Iovance bulk TIL in the treatment of melanoma and likely other cancers with high mutational load solid tumors.
Researchers at Iovance have generated data in collaboration with Roswell Park Cancer Center from the 22-day Gen 2 process of generating TIL from patient derived bladder cancer tumor tissue. An abstract describing the data has been accepted for presentation at the upcoming AACR (Free AACR Whitepaper) "Bladder Cancer: Transforming the Field" conference taking place May 18-21, 2019.
Corporate

In May 2019, the company opened a satellite office in Philadelphia, Pennsylvania. The office will house various functions including members of the Iovance legal and manufacturing teams.
First Quarter 2019 Financial Results

Net loss for the quarter ended March 31, 2019 was $37.0 million, or $0.30 per share, compared to net loss of $26.5 million, or $0.31 per share for the quarter ended March 31, 2018.

Research and development expenses were $30.9 million for the quarter ended March 31, 2019, an increase of $11.0 million, compared to $19.9 million for the same period ended March 31, 2018. The increase in research and development expenses was primarily attributable to an increase in the total number of patients in our clinical studies which in turn results in higher manufacturing and clinical study costs, technology transfer expenses and an increase in research and development headcount.

General and administrative expenses were $9.1 million for the quarter ended March 31, 2019, an increase of $2.1 million compared to $7.0 million for the same period ended March 31, 2018. The increase was primarily attributable to an increase in general and administrative headcount and higher stock based compensation.

Cash, Cash Equivalents and Short-term Investments

At March 31, 2019, the company held $440.0 million in cash, cash equivalents, and short-term investments compared to $468.5 million at December 31, 2018.

Webcast and Conference Call

Iovance will host a conference call and live audio webcast to discuss financial results and provide a corporate update today at 4:30 p.m. EDT.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7393657. The live webcast can be accessed under "News & Events: Investor Calendar" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source An archived webcast will be available in the Investors section of www.iovance.com for thirty days following the call.

On May 7, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2019 financial results and highlighted upcoming milestones (Press release, Kura Oncology, MAY 7, 2019, View Source [SID1234535880]).

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"We have made considerable progress over the past quarter, as we continue to execute against our first registration-directed trial for tipifarnib in patients with HRAS mutant squamous head and neck cancers," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Meanwhile, our elucidation of the CXCL12 pathway as a therapeutic target of tipifarnib, coupled with identification of associated farnesylated proteins, offers the potential to significantly expand the population of patients who may benefit from treatment with tipifarnib. Ultimately, we believe that CXCL12 pathway biomarkers could enable registrational strategies for tipifarnib in multiple hematologic and solid tumor indications."

"Now, we look forward to a series of important milestones," continued Dr. Wilson, "beginning with an update from our ongoing Phase 2 trial of tipifarnib in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12-positive peripheral T-cell lymphoma (PTCL), which was accepted for oral presentation at both the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and the International Conference on Malignant Lymphoma (ICML) next month. This will be followed by additional data from our ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including head and neck squamous cell carcinoma (HNSCC) and other squamous cell carcinomas (SCCs), as well as an update from our ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) later in the year."

Recent Highlights

Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Kura’s global, multi-center, open-label, non-comparative registration-directed trial of tipifarnib continues on track. The clinical trial has two cohorts: A non-interventional screening and outcomes cohort (SEQ-HN) and a treatment cohort (AIM-HN). AIM-HN is designed to enroll at least 59 evaluable patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN initiated in November 2018 and is expected to take approximately two years to fully enroll.

Farnesylated proteins associated with CXCL12 expression – In April 2019, Kura reported new findings at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting suggesting that gene expression of the exclusively farnesylated proteins RHOE and PRICKLE2 is strongly associated with CXCL12 expression in bone marrow stroma. These findings provide key evidence supporting the inhibition of the CXCL12 pathway as a mechanism of action mediating the activity of tipifarnib and other farnesyl transferase inhibitors.

Potential expansion to other CXCL12+ lymphoma indications – Kura reported additional findings at AACR (Free AACR Whitepaper) identifying CXCL12 expression as a potential biomarker of clinical benefit in patients with diffuse large B-cell lymphoma (DLBCL) as well as mycosis fungoides, the most common form of cutaneous T-cell lymphoma (CTCL). The results were obtained from an analysis of a subset of samples from a previously conducted Phase 2 trial of tipifarnib in patients with relapsed and refractory lymphomas and are consistent with similar findings from the Company in other indications such as PTCL, acute myeloid leukemia (AML) and pancreatic cancer.

Emerging pipeline of clinical-stage drug candidates – Kura is advancing two additional pipeline programs: KO-947, a small molecule inhibitor of extracellular signal-related kinase (ERK), and KO-539, a potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) interaction. The Company continues to evaluate dosing regimens for KO-947 and anticipates having data from its Phase 1 clinical trial later this year. Meanwhile, the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KO-539 and the Company is preparing to initiate a Phase 1 clinical trial in patients with relapsed or refractory AML in mid-2019.

Financial Results

Research and development expenses for the first quarter of 2019 were $10.4 million, compared to $11.6 million for the first quarter of 2018.

General and administrative expenses for the first quarter of 2019 were $4.6 million, compared to $3.4 million for the first quarter of 2018.

Net loss for the first quarter of 2019 was $13.9 million, compared to $14.6 million for the first quarter of 2018.

Cash, cash equivalents and short-term investments totaled $165.5 million as of March 31, 2019, compared with $179.0 million as of December 31, 2018.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2021.

Upcoming Milestones

Additional data from the ongoing Phase 2 trial of tipifarnib in PTCL, including duration of response data from the AITL cohort and additional data from the CXCL12-positive PTCL cohort, at EHA (Free EHA Whitepaper) and ICML in June 2019

Additional data on biomarkers associated with elevated CXCL12 expression at EHA (Free EHA Whitepaper) and ICML in June 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including HNSCC and other SCCs, in the second half of 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in CMML in 2019

Data from the Phase 1 dose-escalation trial of KO-947 in 2019

Initiation of the Phase 1 clinical trial of KO-539 in mid-2019

Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 7, 2019, to discuss the financial results for the first quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 4436235. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

On May 7, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, reported its financial results for the first quarter ended March 31, 2019 and provided an update on the company’s recent achievements and anticipated upcoming milestones (Press release, Audentes Therapeutics, MAY 7, 2019, View Source [SID1234535866]).

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"We are excited by the continued strong momentum across our business," stated Matthew R. Patterson, Chairman and Chief Executive Officer. "We recently presented new positive data from ASPIRO, the Phase 1/2 study of AT132 for the treatment of XLMTM, at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper). These data further support the compelling profile of this important product candidate and help further our progress toward the goal of making AT132 globally available to patients living with XLMTM as rapidly as possible."

Mr. Patterson continued, "In our Pompe disease program, this quarter we successfully completed an initial NHP safety study of our product candidate AT845 and the encouraging results give us added confidence as we complete GLP toxicology and dose-ranging studies to support a third quarter IND submission. Finally, we are thrilled to have recently announced the expansion of our technology platform and development pipeline with the addition of programs utilizing vectorized antisense to address Duchenne muscular dystrophy and myotonic dystrophy, two devastating neuromuscular diseases."

Recent Achievements & Upcoming Key Events

AT132 for X-Linked Myotubular Myopathy (XLMTM):

Presented new positive data from ASPIRO at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper).
The ASGCT (Free ASGCT Whitepaper) data set included safety and efficacy assessments out to 48 weeks of follow-up for six treated patients in dose Cohort 1 (1×1014 vg/kg) and 24 weeks for three treated patients in dose Cohort 2 (3×1014 vg/kg).
Patients receiving AT132 achieved reductions in ventilator dependence not previously observed in chronically ventilated patients with neuromuscular disorders, including four patients achieving ventilator independence and all other treated patients demonstrating sustained and clinically meaningful reductions in ventilator use.
The data also demonstrated sustained improvements in neuromuscular function in both dose cohorts with corresponding achievement of clinically meaningful motor milestones. Additionally, muscle biopsy data continued to show robust tissue transduction, protein expression, and histological improvements in 24 and 48-week muscle biopsies in all patients, with evidence of more rapid pathological improvement by week 24 in the Cohort 2 biopsy samples.
AT132 has been generally well-tolerated and has shown a manageable safety profile across both dose cohorts with no clinically meaningful safety differences between doses to date.
Enrollment of an additional three to five patients in Cohort 2 (3×1014 vg/kg) of ASPIRO is ongoing.
On track to select optimal dose of AT132 in the second quarter of 2019. Plan to provide an updated data package to FDA and on track to provide update on the license application submission plans for AT132 in the third quarter of 2019.
Next clinical data presentation planned at the 24th International Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark, October 1-5, 2019.
AT845 for Pompe Disease:

Successfully completed an initial non-GLP NHP study, which showed a clean safety profile.
Previously planned GLP toxicology and dose-ranging studies in progress.
On track to file IND in the third quarter of 2019.
AT702/AT751/AT753 for Duchenne Muscular Dystrophy (DMD):

Announced exclusive license agreement with the Research Institute at Nationwide Children’s Hospital to develop AT702, an AAV-antisense candidate designed to induce exon 2 skipping for DMD caused by duplications of exon 2 and mutations in exons 1-5 of the dystrophin gene. Conducting additional preclinical work of AT702 and plan to commence a Phase 1/2 study at Nationwide Children’s in the fourth quarter of 2019.
Separate from the Nationwide Children’s collaboration, conducting preclinical work to advance AT751 and AT753, additional vectorized exon skipping candidates designed to treat DMD patients with genotypes amenable to exon 51 and exon 53 skipping. Both AT751 and AT753 utilize the same vector construct backbone as AT702, enabling a potentially accelerated path into clinical development.
Initial programs target more than 25% of patients with DMD. Plan to leverage vectorized exon skipping platform to develop further product candidates to address up to 80% of DMD patients over time.
AT466 for Myotonic Dystrophy (DM1):

Collaboration announced with Nationwide Children’s to evaluate vectorized RNA knockdown and vectorized exon skipping for DM1.
Preclinical studies are underway, and IND planned for 2020.
AT342 for Crigler-Najjar Syndrome and AT307 for CASQ2-CPVT:

Completed a strategic review of our product candidates and plan to focus on those programs that have the potential to create the greatest long-term value for patients and shareholders.
Plan to explore outlicensing opportunities to continue to advance these important and promising gene therapy programs.
Manufacturing:

Announced new internal cGMP plasmid manufacturing facility, further establishing the company’s leadership in AAV manufacturing and enabling the rapid advancement of neuromuscular programs from preclinical development to commercialization.
Made continued progress on chemistry, manufacturing, and controls (CMC) BLA and MAA-readiness efforts for AT132 based on FDA and EMA feedback on the company’s preliminary filing strategy.
Corporate:

Expanded leadership team with the additions of Mark Meltz, Senior Vice President, General Counsel, to lead the legal, compliance, and corporate governance functions and Sarah Spencer, Vice President, Corporate Communications, to lead internal and external communications to build global awareness of the company, its mission, culture, and innovative product portfolio.
First Quarter 2019 Financial Results

Cash Position: At March 31, 2019, Audentes had cash, cash equivalents and marketable securities of $375.0 million, which is expected to fund operations into 2021.
Research and Development Expenses: Research and development expenses were $39.8 million for the first quarter of 2019 compared to $19.9 million for the same period in 2018, an increase of $19.9 million. The increase in research and development expense was primarily attributable to increased R&D headcount and related facility costs, a one-time licensing fee of $7.0 million related to the AT702 program, increased internal manufacturing costs, increased clinical trial expenses for our AT132 program, increased pre-clinical and clinical trial planning costs for our AT845 program, and an increase in stock compensation expense.
General and Administrative Expenses: General and administrative expenses were $12.0 million for the first quarter of 2019 compared to $6.5 million for the same period in 2018, an increase of $5.5 million. The increase in general and administrative expenses was primarily attributable to increased headcount and related facility costs, increased professional service and consulting fees, higher costs related to public company regulatory compliance and increase in stock compensation expense.
Net Loss: Net loss was $49.4 million for the first quarter of 2019 compared to $25.6 million for the same period in 2018.
Conference Call
At 4:30 p.m. Eastern Time today, Audentes management will host a conference call and a simultaneous webcast to discuss its first quarter 2019 financial results and provide a corporate update. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investors + Media section of the Audentes website at www.audentestx.com. Alternatively, please call (833) 659-8620 (U.S.) or (409) 767-9247 (international) and dial the conference ID# 6839198 to access the call.

A replay of the webcast will be available on the Audentes website for approximately 30 days.

On May 7, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), reported financial results for the first quarter ended March 31, 2019, including sales of TAVALISSE (fostamatinib disodium hexahydrate), for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment (Press release, Rigel, MAY 7, 2019, View Source [SID1234535865]).

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"Since the U.S. launch of TAVALISSE one year ago, a growing number of physicians are utilizing our product in earlier lines of therapy and with an increasing number of their chronic ITP patients," stated Raul Rodriguez, president and CEO. "Internationally, the recent collaboration with Grifols in Europe enhances our potential access to a majority of the ex-U.S. ITP market. Meanwhile, our pipeline is expanding with the initiation of our Phase 3 trial in warm autoimmune hemolytic anemia and additional ongoing clinical and research projects."

Financial Update

For the first quarter of 2019, Rigel reported a net loss of $17.6 million, or $0.11 per share, compared to a net loss of $24.4 million, or $0.17 per share, in the same period of 2018.

For the first quarter of 2019, Rigel reported total revenues of $12.6 million, consisting of $8.1 million in net product sales of TAVALISSE and $4.6 million in contract revenues from collaborations. The increase in net product sales of TAVALISSE reflects the continuing growth of its business since commercial launch in May 2018. There were no net product sales nor contract revenues from collaborations in the first quarter of 2018.

Contract revenues from collaborations of $4.6 million during the three months ended March 31, 2019 primarily related to a portion of the $30.0 million upfront fee recognized as revenue upon delivery of license rights to Grifols, S.A. and Rigel’s performance of certain research and development services. There were no contract revenues from collaborations during the three months ended March 31, 2018.

Rigel reported total costs and expenses of $31.0 million in the first quarter of 2019, compared to $24.7 million for the same period in 2018. The increase in costs and expense was primarily due to the increases in personnel costs, including its customer-facing and medical affairs teams, and third-party costs to support Rigel’s commercialization of TAVALISSE.

As of March 31, 2019, Rigel had cash, cash equivalents and short-term investments of $127.9 million, compared to $128.5 million as of December 31, 2018.

Business Update

Rigel’s launch of TAVALISSE in the U.S. continued to build upon its early success with growth driven by expansion of the prescriber base, steady use of the product as an early treatment option in steroid refractory patients, physicians prescribing to an increased number of patients, and strong reimbursement from the payer community.
Rigel advanced the regulatory review of fostamatinib in chronic ITP by responding to day-120 questions from the European Medicines Agency (EMA) and remains on track for potential approval in the EU by the end of 2019.
In January, Rigel entered into a collaboration with Grifols, S.A. for the rights to fostamatinib in all indications in Europe and Turkey enabling a commercial launch preparation well ahead of the anticipated approval date.
Kissei Pharmaceuticals, Rigel’s collaborator in Japan, has initiated discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to define a path towards fostamatinib approval in Japan.
In warm AIHA, Rigel opened clinical trial sites for its pivotal Phase 3 clinical study of fostamatinib. The clinical trial protocol calls for approximately 80 patients in a 24-week study with enrollment of the first patient expected this month. Topline trial results are projected in early 2021, positioning fostamatinib to potentially be the first FDA-approved treatment for this indication.
The company’s research and development team continues to investigate potential molecules that modulate the immune system, including R835, Rigel’s IRAK 1/4 inhibitor currently in Phase 1 development. In addition, Rigel has four partnered programs that are in Phase 1 and 2 of their clinical development and continue to advance.
About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
AIHA is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

About R8351
The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 (IL-1R) family receptor signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 is active in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 has not been established by the FDA or any healthcare authority.

Conference Call and Webcast with Slides Today at 4:30PM Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing 855-892-1489 (domestic) or 720-634-2939 (international) and using the Conference ID number 3999559. The webcast, with slide presentation, can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (e.g., rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (e.g., digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

On May 7, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported financial results and business progress for the quarter ended March 31, 2019 (Press release, Genomic Health, MAY 7, 2019, View Source [SID1234535864]).

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"In the first quarter of 2019, we delivered more than 17 percent overall revenue growth and $13.0 million in profit driven by significant growth across all key product areas," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Our first quarter performance was very strong, based in part on the impact of the landmark TAILORx trial results, which are continuing to drive increased Oncotype DX Breast Recurrence Score test usage both in the United States and globally. We expect to achieve double-digit revenue growth for the year with continued growth across key products and look forward to the national reimbursement decision in Germany for the Oncotype DX breast cancer test."

First Quarter Financial Results

Total revenue for the first quarter of 2019 was $108.8 million, compared with $92.6 million for the first quarter of 2018, an increase of 17.4 percent, and an increase of 18.0 percent on a non-GAAP constant currency basis. U.S. product revenue was $91.0 million for the first quarter of 2019, compared with $78.9 million for the first quarter of 2018, an increase of 15.4 percent.

Revenue delivered across key product areas was as follows:

U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score tests was $79.8 million for the first quarter of 2019, compared with $71.0 million for the first quarter of 2018, an increase of 12.5 percent.
U.S. prostate test revenue from Oncotype DX Genomic Prostate Score (GPS) tests was $8.5 million for the first quarter of 2019, compared with $5.8 million for the first quarter of 2018, an increase of 46.6 percent.
International product revenue for the first quarter of 2019 was $17.8 million, compared with $13.8 million for the first quarter of 2018, an increase of 29.0 percent, and an increase of 32.9 percent on a non-GAAP constant currency basis.
Net income was $13.0 million, or $0.35 and $0.34 per share on a basic and diluted basis, respectively, for the first quarter of 2019, an improvement of $16.8 million, compared with a net loss of $3.8 million, or $0.11 per share on a basic and diluted basis, for the first quarter of 2018. Operating income was $11.5 million for the first quarter of 2019, an improvement of $15.9 million, compared with an operating loss of $4.4 million for the first quarter of 2018.

More than 37,580 Oncotype test results were delivered in the first quarter of 2019, an increase of 15.9 percent, compared with more than 32,440 test results delivered in the same period in 2018. Tests delivered across key product areas was as follows:

Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 9.4 percent in the first quarter of 2019, compared with the same period in 2018.
Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 24.5 percent in the first quarter of 2019, compared with the same period in 2018.
Oncotype DX international tests delivered grew 28.1 percent in the first quarter of 2019, compared with the same period in 2018 and represented approximately 25 percent of total test volume in the first quarter of 2019.
Recent Business Highlights

Presented results from five studies at the 16th St. Gallen International Breast Cancer Conference, including real-world evidence that reinforces the treatment paradigm established by the TAILORx trial. Additionally, two decision impact studies from the UK and the Czech Republic highlighted the value of Oncotype DX in personalizing and improving the quality of clinical decisions in patients with early-stage breast cancer, including those with node positive disease .
Multiple private insurers established new coverage for the Oncotype DX Genomic Prostate Score test, bringing the total number of U.S. covered lives to more than 114 million, including Medicare.
First private insurer established reimbursement for the Oncotype DX AR-V7 Nucleus Detect test, bringing the total number of U.S. covered lives to more than 61 million, including Medicare.
The National Comprehensive Cancer Network (NCCN) strengthened its prostate cancer guidelines, recommending the consideration of AR-V7 testing in metastatic castrate resistant prostate cancer (mCRPC) patients following abiraterone/enzalutamide to help guide the selection of further therapy.
Conference Call Details
To access the live conference call today, May 7, 2019, at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 6535029. Please dial in approximately 10 minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company’s website at View Source Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary.