On December 5, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC) (Press release, AbbVie, DEC 5, 2018, View Source [SID1234531917]). An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. For patients currently on treatment with Rova-T in TAHOE, the IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response. The recommendation from the IDMC to halt enrollment applies only to the TAHOE study and does not impact other Rova-T clinical studies.

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"Patients are our first priority and we are deeply grateful to the patients and physicians who participated in this trial," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We remain committed to discovering and developing transformative therapies for people living with cancer."

About the TAHOE Trial
The TAHOE trial is a randomized, open-label, two-arm, Phase 3 trial assessing the efficacy, safety and tolerability of Rova-T versus topotecan in participants with advanced or metastatic small-cell lung cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.

About Rovalpituzumab Tesirine (Rova-T)
Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3)1, which is expressed in more than 80 percent of small-cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.2 Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells. Rova-T is under investigation as a third-line treatment in SCLC.2 The expression of DLL3 suggests Rova-T may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme and some prostate, pancreatic and colorectal cancers.2

Rova-T is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

On December 5, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that updated efficacy and safety results from the ongoing phase 1/2 study of U3-1402, an investigational and potential first-in-class HER3-targeting antibody drug conjugate (ADC), in 42 heavily pretreated patients with HER3-positive metastatic breast cancer were presented during a Spotlight Session at the 2018 San Antonio Breast Cancer Symposium (SABCS) (Press release, Daiichi Sankyo, DEC 5, 2018, View Source [SID1234531918]).

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Updated efficacy data for 42 evaluable patients who received U3-1402 in dose levels between 1.6 mg/kg to 8.0 mg/kg in the dose escalation and dose finding parts of the study showed a confirmed overall response rate of 42.9 percent (18/42 patients) and a disease control rate of 90.5 percent (38/42 patients) at a median follow-up time of 10.5 months. A median duration of response was not reached (range: 2.8, 13.8+). The median progression-free survival was 8.3 months (range: 1.2, 16.8+). Efficacy was observed in all molecular subtypes. A total of 21 patients remain on treatment at the time of data cut-off on November 6, 2018.

"These results offer preliminary evidence of U3-1402 activity in HER3-positive metastatic breast cancer and further study is warranted," said Norikazu Masuda, MD, PhD, National Hospital Organization, Osaka National Hospital, Osaka, Japan, and an investigator for the trial. "The initial efficacy and safety data suggest that a HER3-targeting agent such as U3-1402 could provide a new treatment approach for patients with HER3-expressing metastatic breast cancer, who are in need of additional options to manage their disease."

Updated safety results were also reported. With a median exposure to treatment of 7.6 months, U3-1402 showed a manageable safety profile. The most common adverse events (≥30 percent, any grade) included nausea (85.7 percent), thrombocytopenia (71.4 percent), decreased appetite (66.7 percent), neutropenia (64.3 percent), leukopenia (59.5 percent), vomiting (54.8 percent), AST increased (47.6 percent), ALT increased (45.2 percent), anemia (38.1 percent), stomatitis (35.7 percent) and diarrhea (31.0 percent). The most common adverse events Grade ≥3 (>10 percent of patients) were thrombocytopenia (35.7 percent), neutropenia (28.6 percent), leukopenia (21.4 percent), anemia (16.7 percent) and ALT increased (11.9 percent). Fourteen (14) patients (33.3 percent) experienced serious adverse events regardless of causality, and seven (7) patients (16.7 percent) experienced serious adverse events that were treatment-related. One (1) patient experienced an adverse event leading to treatment discontinuation (2.4 percent), and there were no adverse events leading to death.

"We are encouraged by these preliminary findings with U3-1402, particularly because there are no therapies specifically approved for HER3-expressing breast cancer," said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "Additionally, these findings continue to build evidence that supports the portability of Daiichi Sankyo’s proprietary DXd and linker ADC technology to other targets such as HER3."

About the Phase 1 Study

In this three-part open-label global phase 1/2 study, U3-1402 is given as an intravenous infusion every three weeks. The first part of the study (dose escalation) assessed the safety, tolerability and maximum tolerated dose of U3-1402 in HER3-positive (defined as IHC [immunohistochemistry] 2+/3+) metastatic breast cancer patients who are refractory or intolerant to standard treatment or for whom no standard treatment is available. A maximum tolerated dose has not been reached. Based on preliminary results, dose levels of 4.8 mg/kg and 6.4 mg/kg are being further evaluated. The second part of the study (dose finding) is assessing the safety and efficacy of U3-1402 and determining the recommended phase 2 dose in HER3-positive metastatic breast cancer patients who have received six or fewer prior chemotherapy regimens. The third part of the study (phase 2) is assessing the safety and efficacy of the recommended dose of U3-1402 in HER3-positive metastatic breast cancer patients who have received six or fewer prior chemotherapy regimens. The study is currently enrolling patients in Japan and the U.S. For more information about this study, please visit ClinicalTrials.gov.

About HER3-Positive Metastatic Breast Cancer

HER3 is a member of the human epidermal growth factor receptor family of tyrosine kinase receptors, which are associated with aberrant cell growth.¹ HER3 is overexpressed in several types of solid tumors including breast cancer.² HER3 overexpression has been independently associated with a poorer prognosis and reduced survival for patients with invasive breast cancer.¹ A wide range of incidence of HER3 overexpression has been reported in breast cancer, depending on the screening method and published series.¹ There are currently no targeted therapies approved specifically for HER3-expressing breast cancer or any HER3-expressing cancer.

About U3-1402

Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, U3-1402 is an investigational and potential first-in-class HER3-targeting ADC. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, U3-1402 is comprised of a human anti-HER3 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

U3-1402 is currently being evaluated in two clinical studies, including the phase 1/2 study for HER3-expressing metastatic or unresectable breast cancer in Japan and the U.S., and a phase 1 study for metastatic or unresectable EGFR-mutated non-small cell lung cancer (NSCLC) in the U.S.

U3-1402 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On December 4, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported new data from the Venclexta/Venclyxto (venetoclax) clinical development programme, including longer-term results from the phase III MURANO study in people with previously treated chronic lymphocytic leukaemia (CLL) and updated data from two phase Ib/II studies in people with previously untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy due to coexisting medical conditions (Press release, Hoffmann-La Roche, DEC 4, 2018, View Source [SID1234531851]). Data from the Venclexta/Venclyxto clinical development programme that ranges across multiple blood cancers, including CLL, AML, non-Hodgkin lymphoma and multiple myeloma, will be featured in more than 30 abstracts, including 12 oral presentations, at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting.

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"We’re excited by the versatility of Venclexta/Venclyxto in treating a range of distinct types of blood cancer, including difficult-to-treat forms with limited options," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "These data support our broad clinical development programme through which we hope to discover more ways Venclexta/Venclyxto can be used alone or in combination with other medicines to treat additional types of cancer."

Updated data in CLL
Two new analyses of the phase III MURANO study in relapsed or refractory (R/R) CLL demonstrated the continued clinical benefit of Venclexta/Venclyxto plus MabThera/Rituxan (rituximab) was sustained after patients completed the chemotherapy-free, two-year fixed-duration course of therapy.

An analysis showed the combination reduced the risk of disease progression or death (progression-free survival; PFS, as assessed by investigator) by 84% (HR=0.16; 95% CI: 0.12-0.23; p<0.0001) compared to standard of care bendamustine plus MabThera/Rituxan (BR) after a median three-year follow-up. At three years, 71% of patients in the Venclexta/Venclyxto plus MabThera/Rituxan arm had not experienced disease progression, compared to 15% of patients in the BR arm (median PFS: not reached vs. 17.0 months, respectively). A clinically meaningful benefit in overall survival was also observed in the Venclexta/Venclyxto arm compared to the BR arm (88% vs. 80%, HR=0.50; 95 percent CI: 0.30-0.85). Consistent benefit was observed in all patient subgroups for Venclexta/Venclyxto plus MabThera/Rituxan compared to BR, including high-risk and low-risk groups. Data were presented in an oral session on Saturday, 1 December at 14:45 PST (Abstract #184).
A separate analysis showed higher rates of minimal residual disease (MRD)-negativity observed with Venclexta/Venclyxto plus MabThera/Rituxan compared to BR were sustained after patients completed treatment (62% vs. 13%). MRD-negativity means no cancer can be detected using a specific, highly sensitive test, and was defined as less than 1 CLL cell in 10,000 leukocytes. Importantly, these results were observed in the majority of patients in the Venclexta/Venclyxto arm, including patients in high-risk subgroups and were consistent with the maintained PFS benefit seen with longer follow-up. These data support the utility of MRD in peripheral blood as a predictive marker of clinical outcome. No new safety signals were observed with the treatment combination of Venclexta/Venclyxto plus MabThera/Rituxan. These data will be presented in an oral session on Monday, 3 December at 11:30 PST (Abstract #695).
Updated data in AML
Updated data from the phase Ib M14-358 and phase I/II M14-387 studies evaluating Venclexta/Venclyxto in combination with a hypomethylating agent or low-dose cytarabine (LDAC) in people with previously untreated AML who are ineligible for intensive chemotherapy, will also be presented. These results showed that among patients who were dependent upon blood transfusions at baseline, about half were able to achieve transfusion independence (the absence of transfusions during any consecutive 56 days during the study treatment period). No unexpected safety signals were observed with Venclexta/Venclxyto in combination with hypomethylating agents or LDAC.

The M14-358 study showed high rates of complete remission (with at least partial blood count recovery, CR+CRh) of 67% for those who received Venclexta/Venclyxto plus azacitidine and 71% for those who received Venclexta/Venclyxto plus decitabine. For people taking Venclexta/Venclyxto and azacitadine or decitabine who were dependent on blood transfusions at baseline, 50% and 52% achieved red blood cell transfusion independence, respectively; and 58% or 60% achieved platelet transfusion independence, respectively.
The M14-387 study showed rates of complete remission (with or without full recovery of normal blood cell count, CR+CRi) of 54% in people who received Venclexta/Venclyxto in combination with LDAC and a median duration of remission of 8.1 months. For people taking Venclexta/Venclyxto with LDAC, 48% achieved red blood cell transfusion independence and 60% achieved platelet transfusion independence.
Results from the two studies were presented in an oral session on Sunday, December 2 at 7:45 PST and 8:00 PST, respectively (Abstract #284 and #285).

Based on earlier results from the M14-358 and M14-387 studies, Venclexta was granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of people with newly-diagnosed AML who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. A robust clinical development programme for Venclexta/Venclyxto in AML is ongoing, including two ongoing phase III studies evaluating Venclexta/Venclyxto in combination with azacitidine or with LDAC for people with previously untreated AML who are ineligible for intensive chemotherapy based on results from the M14-358 and M14-387 studies.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States, and commercialised by AbbVie outside of the United States.

About the MURANO study
MURANO (NCT02005471) is a phase III open-label, international, multicentre, randomised study evaluating the efficacy and safety of Venclexta/Venclyxto in combination with MabThera/Rituxan compared to bendamustine in combination with MabThera/Rituxan (BR) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). All treatments were of fixed duration. Following a five-week dose ramp-up schedule for Venclexta/Venclyxto, patients on the Venclexta/Venclyxto plus MabThera/Rituxan arm received six cycles of Venclexta/Venclyxto plus MabThera/Rituxan followed by Venclexta/Venclyxto monotherapy for up to two years total. Patients on the BR arm received six cycles of BR. The study included 389 patients with CLL who had been previously treated with at least one line of therapy. Patients were randomly assigned in a 1:1 ratio to receive either Venclexta/Venclyxto plus MabThera/Rituxan or BR. The primary endpoint of the study was progression-free survival (PFS). Secondary endpoints included overall survival, overall response rate and complete response rate (with or without complete blood count recovery).

About the M14-358 study
The M14-358 study (NCT02203773) is an open-label, non-randomised, phase Ib dose escalation and expansion study evaluating the safety and efficacy of Venclexta/Venclyxto in combination with hypomethylating agents, azacitidine or decitabine, in 115 newly-diagnosed people with acute myeloid leukaemia who were 60 years or older, or ineligible to receive intensive induction chemotherapy due to coexisting medical conditions. Study endpoints included complete remission rates, transfusion independence, overall survival and safety.

About the M14-387 study
The M14-387 study (NCT02287233) is an open-label, single-arm, phase I/II dose escalation and expansion study evaluating the safety and efficacy of Venclexta/Venclyxto in combination with low-dose cytarabine (LDAC) in 82 newly-diagnosed people with acute myeloid leukaemia who were 60 years or older, or ineligible to receive intensive induction chemotherapy due to coexisting medical conditions. Study endpoints included complete remission rates, transfusion independence, overall survival and safety.

About Venclexta/Venclyxto
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States, and commercialised by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

In the US, Venclexta has been granted four Breakthrough Therapy Designations by the FDA: in combination with Rituxan for people with relapsed or refractory chronic lymphocytic leukaemia (CLL); as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine for people with untreated AML ineligible for intensive chemotherapy.

About Chronic Lymphocytic Leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.[1] CLL mainly affects men and the median age at diagnosis is about 70 years.[2] Worldwide, the incidence of all leukaemias is estimated to be more than 400,000[3] and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.[1]

About Acute Myeloid Leukaemia
Acute myeloid leukaemia (AML) is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow.[4] AML is the most common type of aggressive leukaemia in adults. It has the lowest survival rates of all types of leukaemia.[5] Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of <5%.[6;7] Approximately 20,000 people in the US and 18,000 in Europe are diagnosed with AML each year.[8;9]

On December 4, 2018 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the presentation of seven posters highlighting new and updated clinical and preclinical data from its duvelisib development program at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, taking place December 1-4, 2018, in San Diego (Press release, Verastem, DEC 4, 2018, View Source;p=RssLanding&cat=news&id=2379420 [SID1234531868]). Duvelisib is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

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"The PI3K pathway is critical for the survival and proliferation of many types of cancer cells," said Robert Forrester, Verastem President and Chief Executive Officer. "At Verastem Oncology we are committed to progressing the scientific research and clinical development with our corporate, clinical and academic research partners worldwide to unlock the potential of PI3K inhibition and usher in new treatment strategies for patients in need."

"Research being presented at ASH (Free ASH Whitepaper) this year by Chen, et al used CLL patient samples to demonstrate critical points about dual PI3K-delta and PI3K-gamma inhibition," said Jonathan Pachter, PhD, Chief Scientific Officer at Verastem Oncology. "This research suggests that while PI3K-delta inhibition targets the malignant B cells directly, PI3K-gamma inhibition blocks the support of CLL growth by macrophages and T cells in the tumor microenvironment. Data presented show that when CLL cells from patients who progressed on ibrutinib were implanted in mice, dual PI3K-delta and PI3K-gamma inhibition effectively reduced the CLL burden thereby suggesting the potential value of the dual inhibition in tumors resistant to BTK inhibition. The importance of dual inhibition of PI3K-delta and PI3K-gamma, in this case in combination with BCL-2 inhibition, was also described by Ye, et al in an aggressive lymphoma model. This study highlights the synergistic activity of the combination in inhibiting ibrutinib resistance compensatory pathways and inducing apoptosis in preclinical models of Mantle Cell Lymphoma."

"We are delighted to have presented a wide range of data from our ongoing duvelisib development programs, including updated long-term follow-up data from the Phase 3 DUO study as well as the DUO crossover extension study," said Hagop Youssoufian, MSc, MD, Head of Medical Strategy at Verastem Oncology. "Other key presentations include the Zinzani and Lehmberg data, which describe compelling new biomarker research being conducted relating to predictive factors for response to duvelisib in certain hematologic malignancies."

Details for the ASH (Free ASH Whitepaper) 2018 poster presentations are as follows:

Poster Presentations

Title: Clinical and Biological Indicators of Duvelisib Efficacy in CLL from the Phase 3 DUO Study
Presenter: Jennifer Brown, Harvard Medical School and Dana-Farber Cancer Institute
Abstract Number/Publication ID: 1856
Session: 642. CLL: Therapy, excluding Transplantation: Poster I

Title: The Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL: Updated Results from the DUO Crossover Extension Study
Presenter: Matthew Davids, Dana-Farber Cancer Institute
Abstract Number/Publication ID: 3140
Session: 642. CLL: Therapy, excluding Transplantation: Poster II

Title: Characterization of the Long-Term Efficacy and Safety of Duvelisib Monotherapy in Patients with Relapsed/Refractory CLL/SLL on Treatment for > 2 Years across 4 Clinical Studies
Presenter: Ian Flinn, Sarah Cannon Research Institute
Abstract Number/Publication ID: 3146
Session: 642. CLL: Therapy, excluding Transplantation: Poster II

Title: Simultaneous inhibition of BCL-2 and PI3K signaling overcomes ibrutinib resistance in mantle cell lymphoma
Presenter: Haige Ye, MD Anderson Cancer Center
Abstract Number/Publication ID: 2950
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II

Title: Prognostic and Immune-Related Factors for Response to Duvelisib in the Phase 2 DYNAMO Clinical Trial in iNHL
Presenter: Pier Luigi Zinzani, University of Bologna Institute of Hematology
Abstract Number/Publication ID: 4167
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III

Title: Dual Inhibition of PI3K-δ and PI3K-γ by Duvelisib Impairs CLL B Cells and CLL-Supporting Cells and Overcomes Ibrutinib Resistance in a Patient-Derived Xenograft Model
Presenter: Shih-Shih Chen, The Feinstein Institute for Medical Research, Northwell Health
Abstract Number/Publication ID: 4420
Session: 642. CLL: Therapy, excluding Transplantation: Poster III

Title: Dynamic BH3 Profiling Predicts Patient Response and MRD Status in Chronic Lymphocytic Leukemia (CLL) Patients Undergoing Frontline Treatment with Kinase Inhibitor Augmented (KIA) FCR
Presenter: Timothy Z. Lehmberg, Dana-Farber Cancer Institute
Abstract Number/Publication ID: 4395
Session: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster III

PDF copies of these poster presentations will be available here following the conclusion of the meeting.

On December 4, 2018 Clovis Oncology, Inc. (NASDAQ:CLVS) reported after opposition proceedings at The Hague, Netherlands, that the European Patent Office upheld claims of European Patent 2534153 in amended form covering certain crystalline forms of rucaparib camsylate, including rucaparib S-camsylate Form A, the crystalline form in Rubraca (Press release, Clovis Oncology, DEC 4, 2018, View Source [SID1234531884]).

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In its oral decision announced at the hearing, the Opposition Division upheld claims, narrowed from the originally granted patent, to certain crystalline forms of rucaparib camsylate. These forms include, but are not limited to, the commercial product. The European Opposition Division found patentability of the claimed forms based on the inventiveness of these crystalline forms and a constellation of unexpected properties. The European patent was opposed by two opponents. Clovis and/or either opponent have an opportunity to appeal the decision of the European Opposition Division within two months of the written decision, which is expected in the next few months. If appealed, all claims in the originally granted patent will remain in force until the Technical Board of Appeal issues its decision.

In addition to the rucaparib camsylate patent protection through at least 2031 confirmed today, the commercial form of Rubraca is also entitled to European regulatory exclusivity until at least 2028 (and 2029 if an indication in a second tumor type is approved). Also, Clovis has filed for supplementary protection certificate (SPC) extension on this rucaparib camsylate patent in various European countries, which if approved, would provide extension of protection until 2033 under this patent.

"We are very pleased with the outcome of the opposition proceedings today, but more importantly, we are gratified that the European Patent Office acknowledged the innovation behind this invention and upheld robust patent protection for Rubraca in Europe," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This patent represents an important component of the intellectual property for Rubraca and we are happy that the Opposition Division upheld the relevant claims of the patent that cover the commercial form of Rubraca as well as other forms of rucaparib camsylate. We look forward to commercializing Rubraca in Europe and with this outcome, we are well-positioned to do so for a very long time."

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.