On October 30, 2018 INmune Bio, Inc., a cancer immunotherapy company focused on developing therapies that harness the patient’s innate immune system to attack their cancer, reported that RJ Tesi, M.D., CEO and President of the Company, will present a company overview at the upcoming National Investment Banking Association Conference, with details as follows (Press release, INmune Bio, OCT 30, 2018, View Source [SID1234530395]):

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National Investment Banking Association 145th Investment Conference

Date and Time: Thursday November 1, 2018 at 9:30 a.m. Eastern time
Venue: Crowne Plaza Times Square, New York City

On October 30, 2018 Illumina, Inc. (NASDAQ: ILMN) today announces the launch of TruSightTM Oncology 500 (TSO 500), a comprehensive pan-cancer assay designed to identify known and emerging tumor biomarkers (Press release, Illumina, OCT 30, 2018, View Source [SID1234530431]). TruSight Oncology 500 utilizes both DNA and RNA from subject tumor samples to identify key somatic variants underlying tumor progression, such as small DNA variants, fusions, and splice variants. Importantly, TruSight Oncology 500 can measure tumor mutational burden (TMB) and microsatellite instability (MSI), features that are potentially key biomarkers for emerging immunotherapies. TruSight Oncology 500 is for research use only and will ship in Q1 2019.

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Molecular testing in lung cancer has been at the forefront of precision oncology. The use of targeted therapies is associated with improved outcomes in some patients, and currently requires testing multiple biomarkers, such as EGFR mutations, ALK fusions, and ROS fusions, among others. Recently, TMB gained prominence as a biomarker that demonstrates better response and survival from immune checkpoint inhibitors in patients exhibiting high TMB, necessitating the need for comprehensive sequencing. Reliable measurement of TMB in a tumor-only workflow requires sequencing of approximately 1Mb or greater, specific and sensitive variant calling, as well as bioinformatic methods to flag and remove germline variants. Given the increasing number of biomarkers required to fully understand the optimal therapeutic course, assays like TruSight Oncology 500—one of the largest and most comprehensive panels to-date—encompasses all of these biomarkers, making it an ideal choice for cancer researchers today.

"The importance of tumor mutational burden as a biomarker to predict immune checkpoint inhibition response continues to grow in non-small cell lung cancer," said Albrecht Stenzinger, MD, pathologist at University Hospital Heidelberg, Germany. "However, the detection of somatic biomarkers, such as ALK fusions and EGFR small variants, are also vital. The workflow of TSO 500, using both DNA and RNA, enables laboratories to evaluate TMB, as well as small DNA variants and fusions simultaneously, ultimately saving time and preserving precious samples."

"While many methods are arising that measure TMB, these methods may differ in their variant calling performance and their gene content, affecting measurement," said Dr. Carina Heydt, a molecular biologist at the University of Cologne, Institute of Pathology, in Germany. "As an early access site for TSO 500, not only did we find the assay easy to implement in our laboratory, but the enrichment-based chemistry of the assay, coupled with the novel bioinformatic pipeline, demonstrate a high-variant calling performance and reproducible TMB measurements."

Pharmaceutical partners and payers are shifting toward deeper, broader sequencing to help predict which patients may benefit from new treatments including immunotherapies, targeted therapies and the many potential combinations. Recently, Bristol-Myers Squibb Company (NYSE: BMY) and Illumina announced a collaboration to develop and globally commercialize companion diagnostics, based on TruSight Oncology 500 content, to support Bristol-Myers Squibb’s oncology portfolio.

"By focusing on our most differentiated oncology products, we can meet the needs of our customers and provide a comprehensive NGS panel that includes all of the known and anticipated biomarkers associated with targeted and immune-based therapies," said Garret Hampton, Executive Vice President of Clinical Genomics at Illumina. "As we move to bring a future in vitro diagnostic version through regulatory approval, we will be able to set the standard for accurate and reproducible testing. Today’s value in the capability to call for TMB is in line with current research and emerging guidelines, but the promise that TruSight Oncology 500 holds for the future identification of biomarkers, makes it a robust solution for this rapidly evolving field."

TruSight Oncology 500 offers deep, adaptable, and accessible sequencing power:

Goes beyond current cancer guidelines and clinical trials – The deep investigational power of TSO 500 covers a large number of genes – alterations that are being used to identify patients for clinical trials – while covering 1.94Mb of the genome to measure TMB.
Unlocks immunotherapy research – Rigorously developed and accurate TMB and MSI algorithms, with a dedicated tumor-only workflow, while also offering the flexibility to detect a vast majority of known genetic variants, whether it be small variants, gene amplifications, de novo fusions, or splice variants.
Integrated tumor-only, RNA+DNA workflow: The ability to run RNA and DNA biomarkers into one workflow enables a lab to evaluate all relevant biomarkers at the same time. In addition, being able to run tumor-only workflow enables cost savings for a lab since there is no need to run a normal sample each time.

On October 30, 2018 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported financial results for the third quarter ended September 30, 2018 and provided a business update (Press release, Insmed, OCT 30, 2018, View Source [SID1234530643]).

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As previously announced, Insmed received accelerated approval from the U.S. Food and Drug Administration (FDA) on September 28, 2018, for ARIKAYCE (amikacin liposome inhalation suspension) for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. ARIKAYCE is the first and only therapy approved in the U.S. specifically for patients with MAC lung disease.

"With the FDA approval of ARIKAYCE for the treatment of refractory MAC lung disease, the company has taken a monumental step forward on our journey to transform the lives of patients with serious and rare diseases. We are now focused on executing a successful U.S. launch while laying the groundwork for long-term growth," commented Will Lewis, President and Chief Executive Officer of Insmed. "We look forward to working with the FDA on the design of the post-approval confirmatory study required to support the full approval of ARIKAYCE in a front-line setting; continuing to collaborate with regulators in Europe and Japan to support potential regulatory submissions in those regions; and advancing our pipeline to bring other potential therapies to patients with serious and rare diseases."

Recent Corporate Developments

Commercial Launch of ARIKAYCE Under Way

Following the FDA approval of ARIKAYCE, the Company launched its commercial efforts, with its team of 72 therapeutic specialists conducting outreach to pulmonologists and infectious disease physicians. Insmed also launched the Arikares Support Program, which provides dedicated coordinators to help patients navigate the reimbursement process and trainers to provide support to eligible patients in using ARIKAYCE.

Pivotal Phase 3 CONVERT Study Data Published in American Journal of Respiratory and Critical Care Medicine

In September, results from the CONVERT study were published online in the American Journal of Respiratory and Critical Care Medicine. As previously reported, the study showed that the addition of ARIKAYCE to guideline-based therapy (GBT) eliminated evidence of nontuberculous mycobacterial (NTM) lung disease caused by MAC in sputum cultures by Month 6 in 29.0% of patients (65/224), compared to 8.9% of patients (10/112) on GBT alone (p<0.0001).

New Data Presented at Infectious Disease Week (IDWeek) 2018 and CHEST Annual Meeting

In October, Insmed presented data on MAC lung disease and ARIKAYCE at IDWeek 2018 and at the CHEST Annual Meeting. The presentations included an analysis of the rate and risk factors of all-cause mortality in Medicare beneficiaries with NTM lung disease; an analysis of the incidence and prevalence of NTM lung disease among Medicare beneficiaries; two analyses related to susceptibility in the Phase 3 CONVERT study evaluating the safety and efficacy of ARIKAYCE in adult patients with treatment-refractory NTM lung disease caused by MAC; and interim results from INS-312, the ongoing open-label single-arm extension of the CONVERT study, as of July 2017.

Patent Protection in Japan Extended to 2033

In October, the Japanese Patent Office issued its eighth patent to Insmed for amikacin liposome inhalation suspension, extending exclusivity in Japan by nearly seven and a half years to May 2033. The claims of the patent relate, in part, to systems for treating pulmonary infections.

Third Quarter Financial Results

For the third quarter of 2018, Insmed reported a net loss of $87.7 million, or $1.14 per share, compared with a net loss of $45.2 million, or $0.69 per share, for the third quarter of 2017.

Research and development expenses were $39.5 million for the third quarter of 2018, compared with $26.7 million for the third quarter of 2017. The increase is primarily due to an increase in external manufacturing expenses for ARIKAYCE production-related activities and higher compensation and related expenses due to an increase in headcount.

General and administrative expenses for the third quarter of 2018 were $44.4 million, compared with $17.4 million for the third quarter of 2017. The increase is primarily due to an increase in headcount, including the hiring of our field force, and higher consulting expenses related to pre-commercial planning activities in preparation for the launch of ARIKAYCE.

Balance Sheet and Cash Guidance

As of September 30, 2018, Insmed had cash and cash equivalents of $567.6 million. The Company’s operating expenses for the third quarter of 2018 were $84.0 million. The cash-based operating expenses for the third quarter of 2018 were $75.1 million.

The Company is investing in the following key activities in 2018: (i) the build-out of the commercial organization to support the U.S. launch and potential global expansion activities for ARIKAYCE; (ii) manufacturing of commercial inventory and build-out of an additional third-party manufacturing facility; and (iii) clinical trials for ARIKAYCE and the WILLOW study, our Phase 2 development program for INS1007, along with advancement of other pipeline programs. As a result of these activities, Insmed continues to expect cash-based operating expenses and capital and other cash investments to be toward the low end of the range of $150 million to $170 million for the second half of 2018.

Conference Call

Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (844) 707-0669 (domestic) or (703) 639-1223 (international) and referencing conference ID number 2556408. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately two hours after its completion through November 6, 2018 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and referencing conference ID number 2556408. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

Non-GAAP Financial Measures

In addition to the U.S. generally accepted accounting principles (GAAP) results, this earnings release includes cash-based operating expenses, a non-GAAP financial measure, which Insmed defines as total operating expenses excluding stock-based compensation expense and depreciation expense. A reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure is presented in the table attached to this press release.

Management believes that this non-GAAP financial measure is useful to both management and investors in analyzing our ongoing business and operating performance. Management believes that providing non-GAAP information to investors, in addition to the GAAP presentation, allows investors to view our financial results in the way that management views financial results. Management does not intend the presentation of this non-GAAP financial measure to be considered in isolation or as a substitute for results prepared in accordance with GAAP. In addition, this non-GAAP financial measure may differ from similarly named measures used by other companies.

About MAC Lung Disease

Mycobacterium avium complex (MAC) lung disease is a rare and serious disorder that can significantly increase morbidity and mortality. Patients with MAC lung disease can experience a range of symptoms that often worsen over time, including chronic cough, dyspnea, fatigue, fever,

weight loss, and chest pain. In some cases, MAC lung disease can cause severe, even permanent damage to the lungs, and can be fatal.

MAC lung disease is an emerging public health concern worldwide with significant unmet needs. Current guideline-based treatment involves the use of multi-drug regimens that are not specifically approved for MAC lung disease. The course of treatment is often two years or more and is inadequate in treating the disease in many patients.

About ARIKAYCE (amikacin liposome inhalation suspension)

ARIKAYCE is the first and only FDA-approved therapy indicated for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed’s proprietary PULMOVANCE liposomal technology enables the delivery of amikacin directly to the lungs, where it is taken up by lung macrophages where the infection resides. This approach prolongs the release of amikacin in the lungs while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira Nebulizer System manufactured by PARI Pharma GmbH.

About PARI Pharma and the Lamira Nebulizer System

ARIKAYCE (amikacin liposome inhalation suspension) is delivered by a novel inhalation device, the Lamira Nebulizer System, developed by PARI. Lamira is a quiet, portable nebulizer that enables efficient aerosolization of liquid medications, including liposomal formulations such as ARIKAYCE, via a vibrating, perforated membrane. Based on PARI’s 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms and new pharmaceutical formulations that work together to improve patient care.

About CONVERT (INS-212) and INS-312

CONVERT is a randomized, open-label, global Phase 3 trial designed to confirm the sputum culture conversion results seen in Insmed’s Phase 2 clinical trial of ARIKAYCE in patients with refractory NTM lung disease caused by MAC. CONVERT is being conducted in 18 countries at more than 125 sites. The primary efficacy endpoint is the proportion of patients who achieved sputum culture conversion at Month 6 in the ARIKAYCE plus GBT arm compared to the GBT-only arm. Patients who achieved sputum culture conversion by Month 6 are continuing in the CONVERT study for an additional 12 months of treatment following the first monthly negative sputum culture. Patients who did not culture convert may have been eligible to enroll in our INS-312 study. INS-312 is a single-arm open-label extension study for patients who completed six months of treatment in the INS-212 study but did not demonstrate culture conversion by Month 6. Under the study protocol, non-converting patients in the ARIKAYCE plus GBT arm of the INS-212 study will receive an additional 12 months of ARIKAYCE plus GBT. Patients who

crossed over from the GBT-only arm of the INS-212 study will receive 12 months of treatment of ARIKAYCE plus GBT.

On October 30, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will report its third quarter 2018 financial results on Tuesday, November 6, 2018 (Press release, Iovance Biotherapeutics, OCT 30, 2018, View Source;p=irol-newsArticle&ID=2374137 [SID1234530356]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 8718039. The live webcast can be accessed under "News & Events" in the "Investors" section of the Company’s website at View Source, or you may use the link: View Source

A replay of the call will be available from November 6, 2018 at 7:30 p.m. ET to November 13, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 8718039. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source.

On October 30, 2018 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended September 30, 2018, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the remainder of 2018 (Press release, Clovis Oncology, OCT 30, 2018, View Source [SID1234530373]).

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"As discussed last quarter, growth remains challenging in the second-line maintenance ovarian cancer setting, but we have efforts underway to address this and we are aggressively moving forward to grow this market and grow our share of this market," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "In addition, our development team continues to make significant progress in moving Rubraca beyond its initial ovarian cancer indications. In particular, we were very pleased with the data from the TRITON studies presented at ESMO (Free ESMO Whitepaper) and at the Prostate Cancer Foundation Scientific Retreat, which also served as the basis for Breakthrough Therapy designation, and we are committed to developing Rubraca in the prostate setting as rapidly as possible to support men with this difficult-to-treat disease."

Third Quarter 2018 Financial Results

Product revenue for the quarter and first nine months ended September 30, 2018 was $22.8 million and $65.0 million, compared to $16.8 million and $38.5 million for the comparable periods in 2017. The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for the three months ended September 30, 2018 was approximately 30 percent of the overall commercial supply, or the equivalent of $9.6 million in commercial value. In the nine months ended September 30, 2018, the supply of this free drug was approximately 26 percent of the overall commercial supply, or the equivalent of $23 million in commercial value. We believe the increase in the free drug percentage not realized as revenue results primarily from an increase in the percentage of patients treated with Rubraca who qualify for our patient assistance program, the majority of whom are on Medicare, following label expansion to include the earlier-line, all-comers maintenance treatment label.

Clovis had $604.4 million in cash, cash equivalents and available-for-sale securities as of September 30, 2018. Cash used in operating activities was $72.5 million for the third quarter of 2018 and $283.3 million for the first nine months of 2018, compared with $45.8 million for the third quarter of 2017 and $195.3 million for the first nine months of 2017. This includes product supply costs of $76.1 million in the first nine months of 2018 related to Clovis’ previously described plan to build additional inventory in advance of the transition to a new manufacturing facility for Rubraca. Additionally, Clovis made one-time milestone payments to Pfizer of $58 million in the first nine months of 2018 related to U.S. product approvals in December 2016 and April 2018 and European product approval in May 2018.

Clovis reported a net loss for the third quarter of 2018 of $89.9 million, or ($1.71) per share, and $268.8 million, or a net loss of ($5.18) per share for the first nine months of 2018. Net loss was $60.7 million, or a net loss of ($1.24) per share for the third quarter of 2017, and $294.5 million, or a net loss of ($6.39) per share for the first nine months of 2017.

The net loss for the nine months ended September 30, 2018 includes a one-time charge of $20 million in the second quarter related to a final settlement reached with the Securities and Exchange Commission which resolves their investigation related to rociletinib, and a charge of $8.0 million in the first quarter related to a legal settlement. The net loss for the nine months ended September 30, 2017 included a charge of $117.0 million related to a legal settlement. The adjusted net loss excluding these items was $240.8 million, or ($4.64) per share for the first nine months of 2018 and $177.5 million, or ($3.85) per share for the first nine months of 2017.

Net loss for the third quarter and first nine months of 2018 included share-based compensation expense of $10.9 million and $37.7 million, compared to $12.6 million and $32.2 million for the comparable periods of 2017.

Clovis had approximately 52.7 million shares of common stock outstanding as of September 30, 2018.

Research and development expenses totaled $63.9 million for the third quarter of 2018 and $160.1 million for the first nine months of 2018, compared to $38.9 million and $104.5 million for the comparable periods in 2017. Research and development expenses will continue to increase compared to prior year as planned Rubraca studies progress.

Selling, general and administrative expenses totaled $42.5 million for the third quarter of 2018 and $126.6 million for the first nine months of 2018, compared to $35.0 million and $100.4 million for the comparable periods in 2017. Selling, general and administrative expenses will continue to increase compared to prior year in support of administrative and commercial activities related to Rubraca in the United States and Europe.

Guidance for Q4 2018; Anticipate Providing 2019 Guidance in Early January

Based on current trends in PARP inhibitor adoption, the Company anticipates Q4 2018 revenues to be consistent with or slightly higher than Q3 2018 reported revenues of $22.8 million. Clovis anticipates providing full-year 2019 guidance in early January.

Key Milestones and Objectives for Rubraca

European Union (EU) Maintenance Treatment Variation Under Review

Following the receipt of the initial Marketing Authorization for Rubraca in late May 2018, Clovis submitted a variation to include the maintenance indication, which was validated by the European Medicines Agency (EMA) in early July. The review is underway and an opinion for the maintenance indication is anticipated from the EMA’s Committee for Medicinal Products for Human Use (CHMP) by the end of 2018, and, if positive, a potential formal European Commission approval could follow in early 2019. Clovis continues to establish its EU organization to support the planned launch of Rubraca in Europe.

TRITON Datasets at ESMO (Free ESMO Whitepaper) and Breakthrough Therapy Designation

Initial data from the Company’s ongoing TRITON studies of Rubraca in advanced prostate cancer were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress (European Society for Medical Oncology) earlier this month. The initial TRITON2 data show a 44% confirmed objective response rate (ORR) by investigator assessment in 25 RECIST1/PCWG3** response-evaluable patients with a BRCA1/2 alteration. The median duration of response in these patients has not yet been reached. In addition, a 51% confirmed prostate specific antigen (PSA) response rate was observed in 45 PSA response-evaluable patients with a BRCA1/2 alteration. Preliminary safety data for Rubraca in men with mCRPC were consistent with those observed in patients with ovarian cancer and other solid tumors.

The TRITON2 results were the basis for Breakthrough Therapy designation for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy, which was granted on October 2, 2018 by the U.S. Food and Drug Administration (FDA). The TRITON2 study continues to enroll patients.

Also, a TRITON screening poster presented at ESMO (Free ESMO Whitepaper) provided initial genomic profiling data from the TRITON clinical program. Plasma samples identified alterations in BRCA1 or BRCA2 in approximately 12% of mCRPC patients screened for the TRITON2 study, and data demonstrated that plasma cell-free circulating tumor DNA (cfDNA) samples were highly consistent with tumor tissue in identifying BRCA1 or BRCA2 alterations.

Rubraca Clinical Development

Clovis has a robust clinical development program underway in multiple tumor types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials. The following clinical studies are open for enrollment or are anticipated to open during the next several months:

The Clovis-sponsored ARIEL4 confirmatory study in the treatment setting is a Phase 3 multicenter, randomized study of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. This study is currently enrolling patients.
The Clovis-sponsored Phase 3 ATHENA study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating Rubraca plus Opdivo (PD-1 inhibitor), Rubraca, Opdivo and placebo in newly diagnosed patients who have completed platinum-based chemotherapy. This study, as part of a broad clinical collaboration with Bristol-Myers Squibb, is currently enrolling patients
The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in metastatic castration-resistant prostate cancer (mCRPC) enrolling BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on androgen-receptor (AR)-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting. TRITON3 compares Rubraca to physician’s choice of AR-targeted therapy or chemotherapy in these patients. This study is currently enrolling patients.
The Clovis-sponsored TRITON2 study in mCRPC, a Phase 2 single-arm study in patients with BRCA mutations (inclusive of germline and somatic) and also enrolling patients with deleterious mutations of other homologous recombination (HR) repair genes, including ATM. All patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of AR-targeted therapy. This study is currently enrolling patients.
The Clovis-sponsored single-arm Phase 2 open-label monotherapy study of Rubraca in recurrent, metastatic bladder cancer titled ATLAS: A Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. This study is currently enrolling patients.
The Phase 1 RUCA-J study, sponsored by Clovis, is a Phase 1 study to identify the recommended dose of rucaparib in Japanese patients, which will enable development of a bridging strategy and potential inclusion of Japanese sites in planned or ongoing global studies. This study is currently enrolling patients.
The Phase 2, open-label, multi-cohort study evaluating the combination of Rubraca and Opdivo in patients with relapsed ovarian cancer and in patients with locally advanced or metastatic bladder carcinoma. This study is sponsored by Clovis and is expected to begin in early 2019.
The Phase 1/2 combination study of sacituzumab govitecan and Rubraca for the treatment of advanced metastatic TNBC, relapsed platinum-resistant ovarian cancer and metastatic urothelial cancers is sponsored by Clovis and is expected to begin enrolling patients in the first half of 2019.
The Phase 3 pivotal study in advanced triple-negative breast cancer (TNBC) to evaluate Opdivo and Rubraca in combination. This study is sponsored by Bristol-Myers Squibb. The protocol for this study is in development.
The Phase 2 combination study of Opdivo with Rubraca for the treatment of mCRPC. This study, sponsored by Bristol-Myers Squibb, is being conducted as an arm of a larger sponsored prostate cancer study. This study is currently enrolling patients.
The Phase 1b combination study of the cancer immunotherapy Tecentriq (atezolizumab; anti-PDL1) and Rubraca for the treatment of ovarian and triple-negative breast cancers. This study is sponsored by Roche and is currently enrolling patients.
Exploratory studies in other tumor types are also underway.

________________________________

1 Response Evaluation Criteria in Solid Tumors (RECIST) is a standardized methodology for determining therapeutic response to anticancer therapy using changes in lesion appearance on imaging studies.

** Prostate Cancer Working Group (PCWG3) is an international expert committee of prostate cancer clinical investigators who have recommended modifications to RECIST for use in the conduct of trials in metastatic castration-resistant prostate cancer (mCRPC) which were adopted in the TRITON2 protocol.

Lucitanib Clinical Development

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3), which was previously evaluated in breast and lung cancers in partnership with Servier. Clovis has global rights (excluding China) for lucitanib.

Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; data in breast and lung cancer were insufficient to move the program forward. Recent data for a similar drug that inhibits these same three pathways – when combined with a PD-1 inhibitor – are extremely encouraging and represent a validated and alternative hypothesis for the development of lucitanib in combination with a PD-(L)1 inhibitor, and a Clovis-sponsored combination study is now being planned. Clovis also intends to initiate a study of lucitanib in combination with rucaparib, based on encouraging data of VEGF and PARP inhibitors in combination. Each of these studies is expected to initiate before the end of Q1 2019.

Conference Call Details

Clovis will hold a conference call to discuss Q3 2018 results this afternoon, October 30, at 4:30pm ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.393.4306, International participants 734.385.2616, conference ID: 5885294.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S. and EU.