On November 3, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that more than 60 abstracts featuring nine of its approved or investigational medicines will be presented during the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 3-6 in San Diego (Press release, Hoffmann-La Roche , NOV 3, 2016, View Source [SID1234516214]). The abstracts include more than 20 oral presentations across a broad range of medicines and combinations.

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"The breadth of data we are presenting at ASH (Free ASH Whitepaper) this year reflects our deep commitment to people with blood diseases," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "We are excited to share the results of the pivotal GALLIUM study in previously untreated follicular lymphoma, which showed that people treated with Gazyva/Gazyvaro plus chemotherapy lived significantly longer without their disease worsening than those treated with Rituxan/MabThera plus chemotherapy."

The results from the phase III GALLIUM study have been selected for presentation during the Plenary Scientific Session, which honours the top six abstracts submitted to the meeting, as determined by the ASH (Free ASH Whitepaper) Program Committee. Results from other studies of Gazyva/Gazyvaro1 will also be presented at the meeting, including an overall survival update from the phase III GADOLIN study in Rituxan/MabThera2 -refractory indolent (slow-growing) non-Hodgkin lymphoma (NHL) and the first results from the phase III GOYA study in previously untreated diffuse large B-cell lymphoma (DLBCL).

Updated results from the phase III SABRINA study comparing subcutaneous and intravenous Rituxan/MabThera in previously untreated follicular lymphoma will be presented. The US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the subcutaneous formulation of Rituxan, with an action date of June 26, 2017.

Early results will be shared for combinations of Venclexta/Venclyxto with either Gazyva/Gazyvaro or Rituxan/MabThera in chronic lymphocytic leukaemia and certain types of non-Hodgkin lymphoma. Further follow-up from early studies in multiple myeloma and acute myeloid leukaemia that support further investigation of Venclexta/Venclyxto in these diseases will also be presented. Venclexta/Venclyxto is being co-developed by AbbVie and Roche.

The first cohort from a non-interventional study of people with haemophilia will be presented, including real world safety and efficacy data from patients with inhibitors to factor VIII replacement therapy treated with current standard of care according to routine clinical practice. Separately, there are currently three pivotal studies underway to explore the safety and efficacy of emicizumab3 in the treatment of haemophilia A: a phase III study in people 12 years of age or older with haemophilia A with factor VIII inhibitors investigating weekly dosing; a phase III study in people younger than 12 years of age with factor VIII inhibitors investigating weekly dosing; and a phase III study in people 12 years of age or older without factor VIII inhibitors investigating weekly and every other week dosing.

Key abstracts featuring Roche medicines that will be presented at ASH (Free ASH Whitepaper) can be found in the table below.
Follow Roche on Twitter via @Roche and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH16.
Overview of key presentations featuring Roche medicines at ASH (Free ASH Whitepaper) 2016
Medicine Abstract title Abstract number/Presentation details
Gazyva/Gazyvaro
(investigational use) Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free Survival in Patients with Previously Untreated Follicular Lymphoma: Primary Results of the Randomized Phase 3 GALLIUM Study
#6 (Plenary Scientific Session)
04 Dec 2016
2.00–4.00pm PT
Minimal Residual Disease Assessment in Patients with Follicular Lymphoma Treated with Obinutuzumab or Rituximab as First-Line Induction Immunochemotherapy in the Phase III GALLIUM Study
#613 (Oral presentation)
05 Dec 2016
7.00am PT
(7.00–8.30am PT)
Obinutuzumab or Rituximab Plus CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Final Results From an Open Label, Randomized Phase 3 Study (GOYA)
#470 (Oral presentation)
04 Dec 2016
4.45pm PT
(4.30–6.00pm PT)
Gazyva/Gazyvaro
(approved use, updated study results) Obinutuzumab Plus Bendamustine Followed By Obinutuzumab Maintenance Prolongs Overall Survival Compared With Bendamustine Alone in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma: Updated Results of the GADOLIN Study
#615 (Oral presentation)
05 Dec 2016
7.30am PT
(7.00–8.30am PT)
Rituxan/MabThera (subcutaneous formulation)
Longer Term Efficacy and Safety of Subcutaneous Compared with Intravenous Rituximab: Updated Results of The Phase III SABRINA Study
#1103 (Oral presentation)
05 Dec 2016
5.30pm PT
(4.30–6.00pm PT)
Venclexta/Venclyxto
(investigational use) Safety and Efficacy of Venetoclax and Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) And Coexisting Medical Conditions: Final Results of The Run-In Phase of the Randomized CLL14 Trial
#2054 (Poster)
03 Dec 2016
5.30-7.30pm PT
Results of a Phase Ib Study of Venetoclax Plus R- or G-CHOP in Patients with B-cell Non-Hodgkin Lymphoma (CAVALLI)
#3032 (Poster)
04 Dec 2016
6.00-8.00pm PT
Phase 2 Study of Venetoclax plus Rituximab or Randomized Venetoclax plus Bendamustine+Rituximab (BR) versus BR in Patients with Relapsed/Refractory Follicular Lymphoma: Interim Data (CONTRALTO)
#617 (Oral presentation)
05 Dec 2016
8.00am PT
(7.00-8.30am PT)
Safety and Efficacy of Venetoclax Plus Low-Dose Cytarabine in Treatment-Naive Patients Aged ≥65 Years with Acute Myeloid Leukemia (M14-387)
#2843 (Oral presentation)
03 Dec. 2016
10:45am PT
(9.30- 11.00am PT)
Emicizumab
(investigational) Bleeding Events and Safety Outcomes in Patients with Hemophilia A with Inhibitors: A Prospective, Multicenter, Non-Interventional Study
#3800 (Poster)
05 Dec 2016
6.00-8.00pm PT

On November 3, 2016 Cerus Corporation (NASDAQ: CERS) reported financial results for the third quarter ended September 30, 2016 (Press release, Cerus, NOV 3, 2016, View Source [SID1234516264]).

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Recent developments include:
The U.S. Food and Drug Administration’s (FDA) revised recommendations for protecting blood components from Zika virus was expanded to recommend use of pathogen reduction technology and/or an investigational blood screening test to all U.S. blood centers.

The first Cerus U.S. blood center customers have submitted biologics license applications to the FDA to request allowance for the interstate transport of INTERCEPT-treated platelet components.

Hemolife Fundacion Banco Nacional de Sangre became the first blood center to enter into routine use with the INTERCEPT Blood System in Colombia.

Cerus’ global commercial leadership was strengthened with the appointment of Vivek Jayaraman as chief commercial officer.
"U.S. momentum continues to build, with the number of customers initiating INTERCEPT production accelerating from just three at the beginning of the year to 17 customers to date. With another 22 contracted customers slated to begin production, we are in a healthy position for growth," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Beyond platelets and plasma, we are also moving forward with activities related to our red cell program, with plans to submit for European CE Mark approval and to initiate a U.S. Phase III trial."

Revenue
Product revenue for the third quarter of 2016 was $10.2 million, up 26% from the $8.0 million recognized during the same period in 2015. The increase in reported product revenue for the quarter was primarily driven by a year-over-year increase in INTERCEPT disposable kit demand of 30% in our EMEA and U.S. commercial regions. Product revenue for the first nine months of 2016 was $27.1 million, up 10% from the first nine months of 2015, driven primarily by increased kit sales in our EMEA region and sales to U.S. customers.

Revenue from our Biomedical Advanced Research and Development Authority (BARDA) agreement for the three and nine months ended September 30, 2016, was $0.3 million. We did not recognize any revenue from our BARDA agreement during the three and nine months ended September 30, 2015.

The Company continues to expect 2016 global product revenue in the range of $37 million to $40 million with anticipated growth supported by new business opportunities in both its European and U.S. markets.

Gross Margins
Gross margins on product revenue for the third quarter of 2016 were 46%, compared to 31% for the third quarter of 2015. Gross margins on product revenue for the first nine months of 2016 were 46%, compared to 30% for the first nine months of 2015. Gross margins on product revenue for the three and nine months ended September 30, 2016, increased primarily due to the Company’s disposable kit manufacturing agreement with Fresenius Kabi AG, entered into during the fourth quarter of 2015, and efficiencies realized in 2016 related to inventory management.

Operating Expenses
Total operating expenses for the third quarter of 2016 were $19.2 million, compared to $18.7 million for the third quarter of 2015. Total operating expenses for the first nine months of 2016 were $59.0 million, compared to $53.3 million for the first nine months of 2015. Selling, general and administrative expenses increased for the three and nine months ended September 30, 2016, primarily due to increased spending related to selling and marketing activities associated with the commercialization of INTERCEPT in the U.S. market. Research and development expenses drove the majority of the reported increase for the nine months ended September 30, 2016, primarily due to activities associated with clinical development of the red blood cell system, the pursuit of potential premarket applications supplement approvals for the platelet and plasma systems and the initial activities under the BARDA agreement.

Operating and Net Loss
Operating losses during the third quarter of 2016 were $14.3 million, compared to $16.2 million for the third quarter of 2015, and $46.3 million compared to $46.1 million for the nine months ended September 30, 2016 and September 30, 2015, respectively.
Net loss for the third quarter of 2016 was $14.4 million, or $0.14 per diluted share, compared to a net loss of $15.7 million, or $0.17 per diluted share, for the third quarter of 2015. Net loss for the first nine months of 2016 was $49.4 million, or $0.49 per diluted share, compared to a net loss of $41.1 million, or $0.48 per diluted share, for the same period of 2015.

Net loss for the third quarter of 2015 was positively impacted by the mark-to-market adjustments of the Company’s previously outstanding warrants, which resulted in non-cash gains of $1.1 million and $4.7 million during the third quarter of 2015 and first nine months of 2015, respectively. The Company has no remaining outstanding warrants and as such, does not expect mark-to-market adjustments going forward.

Cash, Cash Equivalents and Investments
At September 30, 2016, the Company had cash, cash equivalents and short-term investments of $81.2 million compared to $107.9 million at December 31, 2015.

At September 30, 2016, the Company had approximately $19 million in outstanding debt under its loan agreement with Oxford Finance.

On November 3, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 17 daratumumab abstracts have been accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 3-6 in San Diego, California (Press release, Genmab, NOV 3, 2016, View Source [SID1234516215]). The daratumumab abstracts are sponsored by our collaboration partner Janssen Biotech, Inc., with the exception of one that was based on an investigator-sponsored study, and one that used commercial daratumumab. One abstract on a study with ofatumumab has also been scheduled for a poster presentation at the meeting. All abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org. A list of the key daratumumab abstracts is included below.

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"A number of presentations will highlight additional analyses and details from the daratumumab Phase III POLLUX and CASTOR studies that formed the basis of regulatory filings earlier this year. Additional presentations include the Phase I study of the subcutaneous formulation of daratumumab, data on the immuno-modulatory properties of daratumumab, and novel ‘real life’ clinical practice data on daratumumab plus pomalidomide retreatment of refractory multiple myeloma patients. We are excited that daratumumab will be featured in so many presentations at this key hematology conference," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Key Daratumumab Abstracts
Efficacy of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Relapsed or Refractory Myeloma Based on Prior Lines of Therapy: Updated Analysis of CASTOR – Oral presentation
Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients with 1 to 3 Prior Lines of Therapy: Updated Analysis of POLLUX – Oral presentation
Efficacy of Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Among Patients with 1 to 3 Prior Lines of Therapy Based on Previous Treatment Exposure: Updated Analysis of POLLUX – Oral presentation
Evaluation of Minimal Residual Disease (MRD) in Relapsed/Refractory Multiple Myeloma (RRMM) Patients Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone – Oral presentation
Open-Label, Multicenter, Dose Escalation Phase 1b Study to Assess the Subcutaneous Delivery of Daratumumab in Patients (pts) with Relapsed or Refractory Multiple Myeloma (PAVO) – Oral presentation
Clinical Efficacy of Daratumumab, Pomalidomide and Dexamethasone in Relapsed, Refractory Myeloma Patients: Utility of Retreatment with Daratumumab Among Refractory Patients — Oral presentation
This is an independent study, not sponsored by Janssen.
Daratumumab, Bortezomib and Dexamethasone Versus Bortezomib and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Based on Prior Treatment Exposure: Updated Efficacy Analysis of CASTOR – Poster presentation
Daratumumab in Combination with Lenalidomide Plus Dexamethasone Induces Clonality Increase and T-Cell Expansion: Results from a Phase 3 Randomized Study (POLLUX) – Poster presentation
High-parameter Mass Cytometry (CyTOF) Evaluation of Relapsed/Refractory Multiple Myeloma (MM) Pts (Pts) Treated with Daratumumab Supports Immune Modulation as a Novel Mechanism of Action – Poster presentation

On November 3, 2016 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, reported that three abstracts on the Company’s lead product candidate, BPX-501, including an oral presentation by Dr. Neena Kapoor, to review results from a study of pediatric patients with immune deficiencies, were accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Bellicum Pharmaceuticals, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219233 [SID1234516245]). The Company will also present data highlighting preclinical results from the application of its GoCAR-T and GoTCR technologies in two poster presentations. ASH (Free ASH Whitepaper) 2016 is being held in San Diego, California on December 3-6.

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Investor/Analyst Luncheon

Bellicum will host an investor and analyst luncheon on Monday, December 5, 2016 at 12:15 PM -1:15 PM PST at the San Diego Marriott Gaslamp Quarter Hotel. Management and investigators Dr. Franco Locatelli (Ospedale Pediatrico Bambino Gesù), Dr. Neena Kapoor (Children’s Hospital of Los Angeles), and Dr. Kris Mahadeo (Montefiore Medical Center) will discuss BPX-501 Phase 2 clinical data in the malignant and non-malignant setting. The luncheon will be webcast live and may be accessed from the News & Events section of the Bellicum website. An archived version of the webcast will be available for replay for at least two weeks following the event.

ASH Presentations on Bellicum Programs

BPX-501:

Oral Presentation: "Outcome of Children with Primary Immune-Deficiencies (PIDs) Enrolled in a Phase I-II Trial Based on the Infusion of BPX-501 Donor T Cells Genetically Modified with a Novel Suicide Gene (Inducible Caspase 9, iC9) After T-Cell Depleted HLA-Haploidentical Allogeneic Stem Cell Transplantation (Haplo-HSCT)"

Abstract Number: 72
Session Name: 732.Clinical Allogeneic Transplantation: Results: Predicting Outcome
Date: Saturday, December 3, 2016
Session Time: 7:30 AM – 9:00 AM PST
Presentation Time: 8:45 AM PST

Poster Presentation: "T-Cell Depleted HLA-Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (Haplo-HSCT) Followed by Donor Lymphocyte Infusion with T Cells Transduced with the Inducible Caspase 9 (iC9) Suicide Gene in Children with Hematological Malignancies"

Abstract Number: 4683
Session Name: 732.Clinical Allogeneic Transplantation: Results: Poster III
Date: Monday, December 5, 2016
Presentation Time: 6:00 PM – 8:00 PM PST

Poster Presentation: "Clinical Outcome and Immune Recovery after Adoptive Infusion of BPX-501 Cells (Donor T Cells Transduced with iC9 Suicide Gene) in Children with Hemoglobinopathies and Diamond-Blackfan Anemia Given a/b T-Cell Depleted HLA-Haploidentical Stem Cell Transplantation (HSCT)"

Abstract Number: 2286
Session Name: 732.Clinical Allogeneic Transplantation: Results: Poster I
Date: Saturday, December 3, 2016
Presentation Time: 5:30 PM – 7:30 PM PST

CAR-T Program: (CD123 CARs)

Poster Presentation: "Inducible MyD88/CD40 (iMC) Costimulation Provides Ligand-Dependent Tumor Eradication by CD123-Specific Chimeric Antigen Receptor T Cells"

Abstract Number: 4551
Session Name: 703.Adoptive Immunotherapy: Poster III
Date: Monday, December 5, 2016
Presentation Time: 6:00 PM – 8:00 PM PST

TCR Program: (PRAME and Bob-1 TCRs)

Poster Presentation: "Inducible MyD88/CD40 (iMC) Enhances Proliferation and Survival of Tumor-Specific TCR-Modified T Cells and Improves Anti-Tumor Efficacy in Myeloma"

Abstract Number: 4550
Session Name: 703.Adoptive Immunotherapy: Poster III
Date: Monday, December 5, 2016
Presentation Time: 6:00 PM – 8:00 PM PST

On November 3, 2016 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended September 30, 2016, and provided an update on the Company’s clinical development programs and regulatory outlook for the remainder of 2016 (Press release, Clovis Oncology, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219461 [SID1234516267]).

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"We are actively preparing for a U.S. launch of rucaparib pending FDA’s decision on our NDA, and we have completed our Marketing Authorization Application submission seeking European approval for rucaparib," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Importantly, we remain focused on exploring rucaparib more broadly, and expect several studies to initiate this quarter, including the TRITON2 study in prostate cancer, the ARIEL4 confirmatory study in ovarian cancer and investigator-sponsored studies exploring rucaparib as maintenance therapy in gastroesophageal cancer and also in combination with bevacizumab in ovarian cancer."

Third Quarter 2016 Financial Results

Clovis had $318.8 million in cash, cash equivalents and available-for-sale securities as of September 30, 2016. Cash used in operating activities was $60.3 million for the third quarter of 2016 and $212.0 million for the first nine months of 2016, compared with $71.7 million and $177.4 million for the comparable periods of 2015. Clovis had approximately 38.6 million outstanding shares of common stock as of September 30, 2016.

Clovis reported a net loss of $65.7 million, or ($1.70) per share, for the third quarter of 2016 and $278.4 million or ($7.24) per share for the first nine months of 2016. The net loss for the third quarter of 2015 was $98.6 million or ($2.62) per share and $233.3 million or ($6.62) per share for the first nine months of 2015. Net loss for the third quarter of 2016 included share-based compensation expense of $9.2 million and $29.7 million for the third quarter and the first nine months of 2016, respectively, compared to $12.4 million and $29.5 million for the comparable periods of 2015.

Notably, the net loss for the first nine months of 2016 includes a net expense non-cash impact of $49.9 million relating to the lucitanib product rights recorded in 2013 in connection with the Company’s acquisition of Ethical Oncology Science S.p.A. (EOS), comprised of a $104.5 million non-cash expense for the impairment of the intangible asset, a $25.5 million non-cash expense credit for the reduction in the fair value of the contingent purchase consideration liability and a $29.2 million related non-cash income tax benefit. The adjusted net loss excluding these items was $228.5 million or ($5.95) per share for the first nine months of 2016.

Research and development expenses totaled $54.3 million for the third quarter of 2016, and $196.7 million for the first nine months of 2016, compared to $76.1 million and $193.3 million, respectively, for the comparable periods in 2015. The decrease in expenses for the third quarter is primarily due to decreased development activities for rociletinib compared to the prior year partially offset by higher expenses associated with rucaparib development programs and launch preparation. The increase in expenses for the nine-month period is primarily due to increased development activities for the rucaparib program, launch preparation and increased personnel-related expenses, partially offset by lower expenses related to decreased clinical development activities for rociletinib.

General and administrative expenses totaled $9.2 million for the third quarter of 2016, and $28.5 million for the first nine months of 2016, compared to $8.3 million and $22.3 million for the comparable periods in 2015. The increase year over year is primarily due to higher legal expense and personnel costs for employees engaged in general and administrative activities.

Clovis expects cash used in operating activities for 2016 will total approximately $276 – $286 million, and to end the year with approximately $245 – $255 million in cash, cash equivalents and available-for-sale securities. This change to cash guidance is primarily related to the recent amendment to the worldwide license agreement with Pfizer for rucaparib which allows Clovis the option to defer payment of the milestone payments payable upon U.S. Food and Drug Administration (FDA) approval of a first NDA in the US and European Medicines Authority (EMA) approval of a first Marketing Authorization Application (MAA) in EU to a date that is 18 months after the date of achievement of such milestones, in exchange for certain higher payments related to the achievement of such milestones. The Company anticipates being able to continue to fund operations into 2018 from currently available cash, cash equivalents and available-for-sale securities.

2016 Key Milestones and Objectives for Rucaparib

During the third quarter of 2016, the rucaparib NDA regulatory filing was accepted by FDA for accelerated approval and granted priority review status with a PDUFA date of February 23, 2017. The application is for rucaparib as monotherapy treatment of patients with advanced ovarian cancer with deleterious BRCA-mutated tumors previously treated with two or more chemotherapies. Tumor BRCA mutations include germline and/or somatic mutations. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015.

Foundation Medicine, Clovis’ companion diagnostic partner, has submitted a Premarket Approval (PMA) application for its tissue-based diagnostic assay designed to identify tumor BRCA mutations, including germline and somatic mutations, with the FDA. The timing of the submission is expected to allow for regulatory approval of the companion diagnostic at substantially the same time that rucaparib could be approved.

In addition, the Company submitted an MAA for rucaparib to the European Medicines Agency for a comparable ovarian cancer treatment indication earlier this week.

In October, in support of the potential U.S. commercial launch of rucaparib, we announced the signing of a long-term manufacturing agreement with Lonza, our current manufacturer. We expect that this new agreement for a dedicated manufacturing line will provide security of supply and reduce our cost of goods over time.

Clovis has completed enrollment in the ARIEL3 Phase 3 randomized maintenance study, with data expected to be available in 2H 2017. Pending positive data, the Company intends to follow up with a supplemental NDA (sNDA) for second-line maintenance therapy in women with ovarian cancer who have responded to platinum based therapy.

At the 2016 ESMO (Free ESMO Whitepaper) Congress in early October, the primary efficacy and safety data from the NDA dataset for rucaparib were presented in an oral session, including the following highlights:

The RECIST ORR (objective response rate as assessed by the investigator, which includes complete and partial responses) in the 106 patients evaluable for efficacy was 54% (95% CI: 43.8-63.5).
Duration of response by investigator assessment in the efficacy population was 9.2 months (95% CI: 6.6-11.7 months).
The most common treatment-emergent adverse events (AEs) (all grades) reported in ≥20 percent of patients in the safety population (n=377) included nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), increased ALT/AST (41%) and constipation (40%). The most common Grade 3/4 treatment-emergent AEs reported in ≥10 percent of patients were anemia (25%), asthenia/fatigue (11%) and ALT/AST elevations (11%).
Several clinical studies, including both Clovis-sponsored and investigator-initiated trials, recently initiated or are planned to begin enrolling patients during the fourth quarter. These include the Clovis-sponsored ARIEL4 confirmatory study in advanced BRCA mutant (inclusive of germline and somatic) ovarian cancer; an investigator-sponsored study evaluating rucaparib and bevacizumab in combination as a first-line maintenance therapy for advanced ovarian cancer; the investigator-initiated RUBY study in women with breast cancer whose tumors have a somatic BRCA mutation or homologous recombination deficient (HRD) signature other than a known germline BRCA mutation; the investigator-initiated PLATFORM study in gastroesophageal cancer in the first-line maintenance setting; and the Clovis-sponsored TRITON2 (Trial of Rucaparib in Prostate Indications) study in metastatic castrate-resistant prostate cancer (mCRPC), a Phase 2 single-arm study enrolling patients with BRCA mutations and ATM mutations (both inclusive of germline and somatic) or other deleterious mutations in other homologous recombination (HR) repair genes and all patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of androgen-receptor (AR) targeted therapy.

The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in mCRPC enrolling BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on AR-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting is planned to initiate during the first quarter of 2017. TRITON3 will compare rucaparib to physician’s choice of AR-targeted therapy or chemotherapy in these patients. Also during the first quarter of 2017, the Phase 1b combination study of Genentech’s cancer immunotherapy Tecentriq (atezolizumab; anti-PDL1) and rucaparib for the treatment of gynecological cancers, with a focus on ovarian cancer, is expected to have the first patient initiated (FPI).

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed for advanced ovarian cancer. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015; and its NDA submission for the treatment of advanced ovarian cancer is currently under active review with the FDA. The MAA submission in Europe for a comparable ovarian cancer indication completed during the fourth quarter of 2016. Additionally, rucaparib is being developed as maintenance therapy in the ARIEL3 trial for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) commonly referred to as "BRCA-like." Data from ARIEL3 are expected in 2H 2017, which is expected to be followed by the submission of a sNDA for a second line or later maintenance indication. Clovis is also exploring rucaparib in other solid tumor types with significant BRCA and BRCA-like populations, including prostate, breast and gastroesophageal cancers. Clovis holds worldwide rights for rucaparib.