On April 25, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported financial results for the first quarter ended March 31, 2019 (Press release, Seattle Genetics, APR 25, 2019, View Source [SID1234535402]). The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments and progress with its late-stage clinical programs for cancer.

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"In the first quarter we achieved an important milestone toward becoming a multi-product oncology company with the announcement of positive topline results from the pivotal trial of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer, and we plan to submit an application for approval to the FDA in 2019," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We continue to execute on expanding ADCETRIS use in the two frontline indications, and maintain our 2019 net sales guidance of $610 million to $640 million in the U.S. and Canada. We have also advanced our other late-stage programs, including reaching target enrollment in the HER2CLIMB pivotal trial of tucatinib in HER2-positive metastatic breast cancer. We expect to report topline results from HER2CLIMB in 2019."

ADCETRIS and Late-Stage Pipeline Highlights

ADCETRIS Ex-U.S. Regulatory Activities in Frontline Hodgkin Lymphoma: In February 2019, Takeda received approval from the European Commission to extend the marketing authorization for ADCETRIS to include ADCETRIS in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adult patients with previously untreated CD30-positive stage IV classical Hodgkin lymphoma. As a result, Seattle Genetics received a $30 million milestone payment from Takeda.
Enfortumab Vedotin (EV) Pivotal Trial Positive Topline Results; Data Selected for Oral Presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting: In March 2019, Seattle Genetics and Astellas announced positive topline results from the first cohort of the EV-201 clinical trial that enrolled 128 patients with locally advanced or metastatic urothelial cancer who previously received both platinum chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44 percent objective response rate per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study (EV-101). The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The companies plan to submit a Biologics License Application under the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway in 2019.
Tucatinib HER2CLIMB Pivotal Trial Update: Seattle Genetics previously announced enrollment of 480 patients in the HER2CLIMB trial to enable analysis of the primary endpoint of progression-free survival (PFS), with topline data expected to be reported in 2019. In April 2019, Seattle Genetics achieved enrollment of 120 additional patients in HER2CLIMB to reach the target enrollment of 600 patients to support the analyses of key secondary endpoints, including overall survival as well as PFS in patients with brain metastases.
Tisotumab Vedotin (TV) innovaTV 204 Pivotal Trial Update: In March 2019, Seattle Genetics and Genmab completed enrollment in the innovaTV 204 pivotal trial evaluating TV in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. The trial is designed to support a potential regulatory submission under the FDA’s accelerated approval pathway.
FIRST QUARTER 2019 FINANCIAL RESULTS

Revenues: Total revenues in the first quarter ended March 31, 2019 increased to $195.2 million, compared to $140.6 million for the same period in 2018. Revenues are comprised of the following three components:

Net Product Sales: ADCETRIS net sales for the U.S. and Canada in the first quarter were $135.0 million, a 42 percent increase over net sales of $95.4 million in the first quarter of 2018.
Royalty Revenues: Royalty revenues in the first quarter were $15.6 million, compared to $15.7 million in the first quarter of 2018. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda. First quarter 2019 net sales of ADCETRIS in Takeda’s territories increased over the comparable period in 2018; however, royalty revenues for the period in 2018 included additional amounts attributable to Takeda’s portion of certain third-party royalty obligations that expired at the end of 2018.
Collaboration and License Agreement Revenues: Amounts earned under the company’s ADCETRIS and ADC collaborations were $44.6 million in the first quarter of 2019, compared to $29.6 million for the same period in 2018. Collaboration revenues for the first quarter of 2019 included the earned portion of a $30.0 million milestone from Takeda triggered by European Commission approval of ADCETRIS in combination with AVD in adult patients with previously untreated CD30-positive stage IV classical Hodgkin lymphoma.
Research and Development (R&D) Expenses: R&D expenses in the first quarter were $158.3 million, compared to $152.5 million in the first quarter of 2018. The increase reflects additional investment in the company’s late-stage pipeline including EV, tucatinib and TV.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses in the first quarter were $80.3 million, compared to $66.2 million in the first quarter of 2018. The increase was primarily attributed to costs to support commercialization efforts related to frontline ADCETRIS indications, the company’s late-stage programs and higher infrastructure costs to support the company’s continued growth.

Non-cash, share-based compensation cost for the first three months of 2019 was $25.7 million, compared to $16.8 million for the same period in 2018.

Net Loss

Net loss for the first quarter of 2019 was $13.3 million, or $0.08 per diluted share, compared to a net loss of $111.7 million, or $0.73 per diluted share, for the first quarter of 2018. Net loss in the first quarter of 2019 included a non-cash net investment gain of $38.1 million associated with Seattle Genetics’ common stock holdings in Immunomedics, which are marked-to-market.

Cash and Investments

As of March 31, 2019, cash and investments were $418.3 million. In addition, the company held stock investments, primarily in Immunomedics common stock, valued at $151.9 million.

2019 FINANCIAL OUTLOOK

The company’s 2019 financial guidance is detailed below, including updates to its expectations for R&D and SG&A expenses driven primarily by positive results from the EV-201 pivotal trial.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast with supporting slides to discuss its first quarter 2019 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event and supporting slides will be simultaneously webcast on the Seattle Genetics website at www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 877-260-1479 (domestic) or 334-323-0522 (international). The conference ID is 6169352. A replay of the live event and supporting slides will be available for at least 30 days. A replay of the audio only will be available by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 6169352. The telephone replay will be available until 5:00 p.m. PT on April 29, 2019.

On April 25, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that abstracts related to trials of the company’s lead therapeutic, vofatamab, have been accepted for presentation at the upcoming 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place May 31 to June 4, 2019 in Chicago, Illinois (Press release, Rainier Therapeutics, APR 25, 2019, View Source [SID1234535401]).

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"We are pleased to have abstracts related to our ongoing Phase 2 vofatamab trials accepted for a poster discussion and poster presentations at ASCO (Free ASCO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes a preliminary analysis of clinical activity in FIERCE-22 and an interim analysis in FIERCE-21."

Poster Discussion & Poster Presentation:

FIERCE-22: Clinical activity of vofatamab (V) a FGFR3 selective inhibitor in combination with pembrolizumab (P) in WT metastatic urothelial carcinoma, preliminary analysis.

Abstract: 4511

Poster Discussion Session: Genitourinary (Nonprostate) Cancer
Date/Time: Monday, June 3, 2019, 4:30 PM – 6:00 PM,
Location: Hall D2

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #337
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM,
Location: Hall A

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

Poster Presentation:

Interim analysis of the FIERCE-21 phase 2 (P2) study of vofatamab (B-701), a selective inhibitor of FGFR3, as salvage therapy in metastatic urothelial carcinoma (mUC).

Abstract: 4547

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #373
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM
Location: Hall A

Presenter: Begona Mellado, MD, PhD, Hospital Clinic de Barcelona

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-21 and FIERCE-22.

FIERCE-21 is a Phase 2 trial evaluating vofatamab in combination with docetaxel and separately vofatamab as monotherapy in patients with locally advanced or metastatic bladder cancer with FGFR3 mutation/fusions who have relapsed after, or are refractory to, at least one prior line of chemotherapy.

FIERCE-22 is a Phase 2 trial evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

For additional information on FIERCE-21, please visit www.clinicaltrials.gov (NCT02401542) and for more information on FIERCE-22, please visit www.clinicaltrials.gov (NCT03123055).

Rainier Therapeutics also plans to study vofatamab in non-muscle invasive bladder cancer (NMIBC) – the FIERCE-23 trial.

On April 25, 2019 Baxter International Inc. (NYSE:BAX), a leading global medical products company, reported results for the first quarter of 2019 and increased its full-year 2019 earnings outlook (Press release, Baxter, APR 25, 2019, View Source [SID1234535400]).

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"We are pleased with the solid start to 2019, establishing a foundation for accelerating performance over the course of the year," said José (Joe) E. Almeida, chairman and chief executive officer. "Our first quarter results reflect the value of our diversified portfolio, an increased emphasis on high-value innovation and an ongoing focus on operational excellence. We remain committed to executing on our strategy to deliver enhanced performance in 2019 and beyond."

First-Quarter Financial Results

Worldwide sales in the first quarter totaled approximately $2.6 billion, a decrease of 2% on a reported basis and an increase of 2% on both a constant currency and an operational basis. Operational sales in the first quarter exclude the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

Sales in the U.S. totaled $1.1 billion, decreasing 2% on both a reported and operational basis. International sales of $1.5 billion decreased 1% on a reported basis and increased 5% on a constant currency basis.

Performance in the quarter was driven by growth of Baxter’s peritoneal dialysis and continuous renal replacement therapies, certain generic injectable pharmaceuticals, and hemostats and sealants. In addition, increased demand for Baxter’s hospital pharmacy compounding and cytotoxic contract manufacturing services also contributed to growth in the quarter. Sales growth in the quarter was partially offset by expected lower sales of Medication Delivery and Nutritional therapies. Baxter’s performance in International markets reflects growth across both the Europe, Middle East and Africa (EMEA) and Asia Pacific (APAC) regions.

Please see the attached schedules accompanying this press release for additional details on sales performance in the quarter, including breakouts by Baxter’s three geographic segments and six global business units (GBUs).

Baxter reported net income of $347 million, or $0.66 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the first quarter. These results include special items totaling $52 million after-tax, which were primarily related to business optimization charges and intangible asset amortization, partially offset by an insurance recovery from a legacy product-related matter. On an adjusted basis, Baxter’s first quarter net income totaled $399 million, or $0.76 per diluted share, ahead of the company’s expectations of $0.66 to $0.68 per diluted share. Adjusted earnings per diluted share advanced 9% in the quarter, driven by solid operational performance as well as benefits from a lower tax rate and share count as compared to the prior-year period.

Business Highlights

Baxter continues to achieve notable milestones in pursuit of its Mission for patients and emphasis on accelerating profitable growth. Among recent highlights, the company:

Launched ready-to-use eptifibatide, a platelet aggregation inhibitor that prevents platelets from sticking together and clotting, using the company’s proprietary GALAXY container technology. Baxter’s premix presentation is the first of its kind available in a flexible container, offering healthcare providers preparation efficiencies and helping to avoid potential dosing errors.
Announced U.S. Food and Drug Administration (FDA) approval for faster preparation of Floseal Hemostatic Matrix. This next generation of Floseal has 20% fewer components and steps to prepare,2 making it easier and faster for operating room nurses to get Floseal into the hands of surgeons to help stop bleeding during procedures.
Initiated a collaboration with bioMérieux, a world leader in the field of in vitro diagnostics, to develop future biomarkers with the goal of rapidly identifying and informing treatment of acute kidney injury (AKI). The efforts are meant to help diagnose AKI earlier so a patient can have improved therapy options, reflecting Baxter’s growth strategy of addressing patient needs across the continuum of care.
Announced that a NantHealth digital health solution is now available to connect Baxter’s Prismaflex technology, used in the intensive care unit to treat patients with acute kidney injury, to a hospital’s electronic medical record (EMR) system. Digitally connected healthcare solutions have the potential to positively impact patient care in many ways, from reducing reliance on manual documentation to converting data into meaningful insights to improve care.
Announced the planned U.S. launch of Clinolipid (20% Lipid Injectable Emulsion), Baxter’s proprietary olive oil-based lipid emulsion, later this year. The announcement was made at the 2019 ASPEN Nutrition Science & Practice Conference, where Baxter featured its diverse portfolio of parenteral nutrition products to address and help improve care for malnourished patients.
Received recognition from multiple organizations for its commitment to workplace excellence, including:
Forbes Magazine, which included Baxter on its annual list of America’s Best Large Employers for the fifth consecutive year.
The National Association for Female Executives (NAFE), which cited Baxter among its 2019 NAFE Top Companies for Executive Women.
The Human Rights Campaign Foundation (HRC), which cited Baxter as a 2019 Best Place to Work for LGBTQ Equality based on Baxter’s perfect score on HRC’s Corporate Equality Index.
2019 Financial Outlook

For full-year 2019: Based on solid first quarter performance, Baxter is raising its earnings outlook for 2019. The company now expects adjusted earnings from continuing operations, before special items, of $3.27 to $3.35 per diluted share. The company continues to expect sales growth of 0 to 1 percent on a reported basis, 2 to 3 percent on a constant currency basis and 3 to 4 percent on an operational basis.

For second-quarter 2019: The company expects sales to decline approximately 2 percent on a reported basis, and to grow approximately 2 percent on a constant currency basis and 2 to 3 percent on an operational basis. The company expects adjusted earnings from continuing operations, before special items, of $0.80 to $0.82 per diluted share.

Full-year and quarterly operational sales estimates for 2019 have been adjusted for the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

A webcast of Baxter’s first-quarter 2019 conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on April 25, 2019. Please see www.baxter.com for more information regarding this and future investor events and webcasts.

On April 25, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and Daiichi Sankyo Company, Limited ("Daiichi Sankyo") reported that Daiichi Sankyo has exercised its option for a commercial license to a proprietary immuno-oncology bispecific built on Zymeworks’ Azymetric and EFECT platforms (Press release, Zymeworks, APR 25, 2019, https://www.businesswire.com/news/home/20190425005026/en/Daiichi-Sankyo-Selects-Lead-Candidate-Built-Zymeworks%E2%80%99 [SID1234535399]). Zymeworks will receive a US$3.5 million payment based on Daiichi Sankyo’s selection of the first of up to three lead product candidates under its collaboration agreements with Zymeworks.

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"This is another example of how our Azymetric platform can facilitate the rapid selection and development of bispecific antibody candidates for our pharmaceutical partners," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "We are thrilled to see Daiichi Sankyo move this novel therapeutic program into late-stage preclinical development. This is an important step forward towards our shared goal of improving the standard of care for patients with cancer."

"Our partnership with Zymeworks has allowed us to develop therapeutic candidates based on complex mechanisms of action such as immune cell engagement," said Antoine Yver, M.D., M.Sc., Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Through this partnership, we have identified a novel bispecific therapeutic that we are excited to be advancing towards the clinic. We look forward to continuing our strong partnership with Zymeworks to develop novel therapeutic options for patients with cancer worldwide."

Under the terms of the 2016 cross-licensing and collaboration agreement, Zymeworks granted Daiichi Sankyo a license to Zymeworks’ Azymetric and EFECT platforms to develop a bispecific antibody therapeutic for which Zymeworks is eligible to receive further clinical and commercial milestone payments of up to US$143.4 million, as well as up to double-digit tiered royalties on global product sales. Additionally, Zymeworks obtained a license to certain immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop, and commercialize multiple bispecific products globally in exchange for royalties on global product sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

On April 25, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three months ended March 31, 2019 (Press release, Odonate Therapeutics, APR 25, 2019, View Source [SID1234535398]).

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As of March 31, 2019, Odonate had $112.1 million in cash, compared to $139.1 million as of December 31, 2018. This decrease in cash resulted primarily from net cash used in operating activities of $27.1 million. Odonate’s net loss for the three months ended March 31, 2019 was $28.6 million, or $1.16 per share, compared to $16.9 million, or $0.69 per share, for the same period in 2018.

"In the first quarter of 2019, we expanded the development of tesetaxel by initiating two new clinical studies, CONTESSA 2 and CONTESSA TRIO, the first study to investigate tesetaxel in combination with PD-(L)1 inhibitors," said Kevin Tang, Chief Executive Officer of Odonate. "We continue to expect to complete enrollment in CONTESSA, our ongoing multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with metastatic breast cancer, in the second half of 2019 and report top-line results in 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of multiple studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with locally advanced or metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC. To learn more, please visit www.contessastudy.com.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive LA/MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system metastases are eligible for both cohorts.