On October 29, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported updated data from a Phase 2 clinical trial of its lead drug candidate, tipifarnib, that show durable anti-tumor activity as a single agent in heavily pretreated patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) (Press release, Kura Oncology, OCT 29, 2019, View Source [SID1234549975]). The results are being presented today at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston. Copies of the oral and poster presentations are available online at www.kuraoncology.com.

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As of the October 17, 2019 data cutoff date, a total of 21 HNSCC patients with high HRAS mutant variant allele frequency1 were enrolled in this Phase 2 trial (RUN-HN), of whom 18 were evaluable for efficacy. Ten of the 18 evaluable patients achieved a confirmed partial response (PR), as defined by standard RECIST criteria, for an objective response rate (ORR) of 56% (95% CI 0.31, 0.78). In addition, eight patients experienced disease stabilization, including two who achieved an unconfirmed PR, one of whom is awaiting a confirmatory response assessment. Of the three non-evaluable patients, two discontinued prior to an initial response assessment and one was awaiting an initial response assessment as of the data cutoff date.

The median progression-free survival (PFS) of the 18 evaluable patients treated with tipifarnib was 6.1 months, compared to 2.8 months on their last prior therapy, including 8.3 months among patients who achieved a PR on tipifarnib and 4.5 months for those with stable disease. Patients had a median of two prior lines of therapy (range 0-6), with no responses observed on their last prior therapy.

Overall response rates for the three therapies approved for treatment of HNSCC in the second line, Keytruda (pembrolizumab), Opdivo (nivolumab) and Erbitux (cetuximab), range from 13-16%, with progression-free survival of approximately two months.

"Tipifarnib is a targeted therapy that has demonstrated rapid and durable anti-tumor activity as a single agent in patients with head and neck squamous cell carcinomas that carry HRAS mutations, a disease that can be resistant to current standards of care, including immunotherapy," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study.

An analysis of preliminary data from the RUN-HN trial performed in October 2018 showed a significant association between tumor HRAS mutant allele frequency and clinical benefit from tipifarnib. Based upon these observations, Kura introduced a minimum HRAS mutant variant allele frequency as an entry criterion prior to the initiation of its registration-directed trial of tipifarnib in HRAS mutant HNSCC (AIM-HN) in November 2018. Concurrently, Kura also incorporated the HRAS mutant variant allele frequency entry criterion into the ongoing RUN-HN trial, which continued to enroll patients at clinical sites that had yet to open in the AIM-HN trial.

As of the October 17, 2019 data cutoff date, 10 new patients with high HRAS mutant variant allele frequency were prospectively enrolled in the RUN-HN trial. Of the eight evaluable patients, three achieved a confirmed PR and five had stable disease, including two who achieved an unconfirmed PR, one of whom is awaiting a confirmatory response assessment. Of the two non-evaluable patients, one discontinued prior to an initial tumor response assessment and one was awaiting an initial response assessment as of the data cutoff date.

Data from The Cancer Genome Atlas (TCGA HNSCC, provisional) indicate that patients with an HRAS mutant allele frequency greater than 20% represent approximately 5% of the overall HNSCC population.

Treatment-emergent adverse events in the trial were consistent with the known safety profile of tipifarnib. The most frequently observed adverse events were hematological-related and were managed with best supportive care and/or dose interruption.

Notably, a total of five evaluable HNSCC patients started at the 600 mg dose in the RUN-HN trial, all of whom achieved an objective clinical response. Patients in the RUN-HN trial received oral doses ranging from 600 mg to 900 mg twice daily, however improved tolerability was observed with the 600 mg bid dose administered days 1-7 and 15-21 every 28-days, which is the recommended starting dose in the ongoing AIM-HN registration-directed trial.

"These results increase our confidence in the probability of success of our registration strategy in HRAS mutant HNSCC," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "In addition to confirming the association between high HRAS mutant variant allele frequency and anti-tumor activity, these data show that the tipifarnib 600 mg bid dose is well tolerated and sufficient to drive clinical activity. Of note, this multi-center study included a number of clinical sites around the world, providing a real-world experience that further increases our confidence in the outcome of our AIM-HN registration-directed trial."

1 HRAS variant allele frequency >35%, or ≥ 20% if serum albumin ≥ 3.5 g/dL

About Tipifarnib

Kura Oncology’s lead drug candidate, tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen in December 2014. In November 2018, following an end of Phase 2 meeting with the U.S. Food and Drug Administration, Kura initiated its first registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC. The clinical trial has two cohorts: A non-interventional screening and outcomes cohort (SEQ-HN) and a treatment cohort (AIM-HN). AIM-HN is designed to enroll at least 59 evaluable patients with HRAS mutant HNSCC who have received prior platinum-based therapy, and is expected to take approximately two years to fully enroll. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

On October 29, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported new preclinical data for SY-5609, its highly-selective and potent oral inhibitor of cyclin-dependent kinase 7 (CDK7) (Press release, Syros Pharmaceuticals, OCT 29, 2019, View Source [SID1234549991]). The data demonstrate that SY-5609 induces deep and sustained anti-tumor activity, including complete regressions, in multiple preclinical models of solid tumors at doses below the maximum tolerated dose (MTD). These data were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston.

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"We are excited to share these new preclinical data for SY-5609, which speak to its potential as a best-in-class oral CDK7 inhibitor and reinforce our conviction in CDK7 inhibition as a potentially transformative approach for difficult-to-treat cancers," said Eric R. Olson, Ph.D., Syros’ Chief Scientific Officer. "We are particularly encouraged that SY-5609 as a single agent induced rapid and dose-dependent tumor growth inhibition in preclinical models of lung, breast and ovarian cancers, and by the observation that sustained regressions are associated with RB pathway alterations. These data support the focus of our planned Phase 1 trial on those patient populations, which we believe are most likely to benefit from treatment with SY-5609, and we look forward to initiating the study early next year."

New Preclinical Data on SY-5609 Highlight Broad Potential Across Solid Tumor Types

Researchers from Syros conducted a series of preclinical studies to characterize the in vitro and in vivo profile of SY-5609. The data show that SY-5609 induced:

Dose-dependent tumor growth inhibition in ovarian and breast cancer models, with tumor regressions observed at doses as low as one-fifth of the MTD.
Rapid, sustained and dose-dependent transcriptional pharmacodynamic responses in xenograft tumor tissue that correlated with tumor growth inhibition.
Substantial tumor growth inhibition in 100% (12/12) of triple negative breast cancer, small cell lung cancer and high grade serous ovarian cancer models tested, including deep and sustained regressions in 58% (7/12) of these models, at well-tolerated doses.
RB pathway alterations were associated with deeper and more sustained responses.
Robust anti-tumor activity in combination with fulvestrant in treatment-resistant models of estrogen receptor-positive breast cancer, including models that were resistant to both fulvestrant and a CDK4/6 inhibitor.
Additionally, the data suggest that SY-5609 plasma exposures are dose proportional and do not accumulate with repeated daily dosing at therapeutic doses and that the overall pharmacokinetic profile supports a daily dosing regimen.

Syros expects to complete investigational new drug application-enabling studies for SY-5609 by year-end. The Company plans to initiate a Phase 1 trial in patients with select solid tumors, including breast, lung and ovarian cancers, and in solid tumors of any histology harboring RB pathway alterations, in the first quarter of 2020.

The poster presented at AACR (Free AACR Whitepaper)-NCI-EORTC is now available on the Publications and Abstracts section of the Syros website at www.syros.com.

On October 29, 2019 Fresenius Medical Care, the world’s leading provider of dialysis products and services, reported the appointment of Dr. Frank Maddux, 61, the company’s Global Chief Medical Officer, to the Management Board (Press release, Fresenius, OCT 29, 2019, View Source [SID1234549958]). He will start in his new position on January 1, 2020.

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Dr. Maddux was appointed Global Chief Medical Officer in March of this year with the goal of enhancing cooperation and the exchange of medical knowledge across the Fresenius Medical Care network, in order to ensure high-quality outcomes for patients worldwide. Now, by adding this position to the Management Board, Fresenius Medical Care is further underlining its commitment to applying clinical science at an ever-higher level.

Dr. Maddux is a physician, IT entrepreneur and healthcare executive with more than 30 years of experience in healthcare. He has been with Fresenius Medical Care since 2009. Before his appointment as Global Chief Medical Officer, he served as Executive Vice President for Clinical & Scientific Affairs and Chief Medical Officer for Fresenius Medical Care North America, where he was responsible for the delivery of high-quality, value-based care for the largest integrated renal care network in the United States. His great expertise and research interests have focused on the quality of care for chronic kidney disease patients.

Stephan Sturm, Chairman of the Supervisory Board of Fresenius Medical Care Management AG, said: "As Global Chief Medical Officer, Dr. Frank Maddux enjoys an outstanding reputation both inside and outside of Fresenius Medical Care. With his proven medical competence and experience, which he can contribute, he will be a great addition to the company’s Management Board."

Rice Powell, Chief Executive Officer of Fresenius Medical Care and Chairman of the Management Board, said: "Dr. Frank Maddux will be key to our ability to drive value for our patients by pursuing new and evolving medical opportunities, such as a more-focused home therapies offering, regenerative medicine, and enhancing our Care Coordination business model throughout the world. We are fortunate to have a Global Chief Medical Officer as qualified and experienced as Dr. Maddux joining our Management Board."

Dr. Maddux said: "The well-being of our patients is our priority, and key to our company’s success. To continuously deliver on this global commitment, I am moved by the power of ideas, conceived by individuals, molded by collective intelligence and brought to life by investment in a higher purpose that is dedicated to improving the lives of people. I am proud of the importance that medical science has for Fresenius Medical Care."

On October 29, 2019 Lantern Pharma, a clinical stage oncology biotech leveraging A.I., machine learning (ML) and genomics, reported that it has selected Reprocell to provide preclinical screening and drug sensitivity work for its portfolio of oncology drugs (Press release, Lantern Pharma, OCT 29, 2019, View Source;utm_medium=rss&utm_campaign=lantern-pharma-selects-reprocell-inc-to-provide-preclinical-screening-and-biomarker-discovery-services-for-portfolio-of-targeted-oncology-drugs [SID1234549976]).

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The collaboration is designed to obtain millions of data points using panels of unique and genetically edited cell lines from various tumors. The data generated from these studies will help Lantern’s AI platform to generate the biological and genetic basis for drug positioning and maximum drug efficacy. Lantern believes this will help bring oncology therapies to patients more efficiently and affordably than traditional R&D efforts.

These collaborative studies will help demonstrate the tremendous potential for patient stratification for cancer therapies. Following the acquisition of data on cell line panels, Reprocell and Lantern will continue to develop subsequent models including 3D, organoid, and PDX models in the drugs journey from preclinical to clinical stages.

"We are pleased to announce this partnership with Reprocell, a relationship we believe will fuel innovation founded on our mutual abilities to leverage highly advanced cell biology data and rapid A.I.-based machine learning to draw relevant and unique conclusions related to drug development," said Panna Sharma, CEO of Lantern Pharma. "We anticipate this collaboration resulting in a clear vision of how to leverage the initial screening of efficacy of our active compounds against a variety of tumors, and how that data can inform personalized treatment decisions for patients."

On October 29, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported financial results for the third quarter and nine months ended September 30, 2019 (Press release, Seattle Genetics, OCT 29, 2019, View Source [SID1234549992]). The Company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities and progress with its late-stage oncology portfolio.

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"We are executing on our vision of becoming a multi-product global oncology company, recently achieving several important milestones across our late-stage pipeline," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "The FDA granted Priority Review to the enfortumab vedotin Biologics License Application for patients with locally advanced or metastatic urothelial cancer, and we recently announced positive topline results from the pivotal HER2CLIMB trial of tucatinib in metastatic HER2-positive breast cancer. This progress is in addition to continued sales growth of ADCETRIS, driven by further adoption in frontline CD30-expressing peripheral T-cell lymphomas as well as frontline advanced Hodgkin lymphoma. We anticipate global sales of ADCETRIS to exceed $1.0 billion in 2019."

Program Highlights

ADCETRIS

Expanding Clinical Development Program: Initiated a trial evaluating frontline treatment with ADCETRIS in Hodgkin lymphoma and peripheral T-cell lymphoma patients who are unfit for combination chemotherapy and a trial evaluating retreatment with ADCETRIS in Hodgkin and T-cell lymphoma patients who progress after a prior response, including in the frontline setting. In addition, initiated a phase 2 trial evaluating ADCETRIS in combination with Opdivo (nivolumab), doxorubicin and dacarbazine in frontline advanced Hodgkin lymphoma. The regimen excludes vinblastine, which is a common component in regimens to treat Hodgkin lymphoma but is associated with neurotoxicity.
Multiple Abstracts Expected at ASH (Free ASH Whitepaper): ADCETRIS will be featured in multiple abstracts at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), taking place December 7-10, 2019 in Orlando, Fla. Data will include a four-year update from the ECHELON-1 trial in frontline stage III and IV Hodgkin lymphoma.
Enfortumab Vedotin

Enfortumab Vedotin Biologics License Application (BLA) Granted Priority Review by the FDA: In September 2019, the FDA accepted the BLA for enfortumab vedotin and granted the application Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020. The FDA granted enfortumab vedotin Breakthrough Therapy designation in March 2018 for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy.
Reported Initial Data from EV-103 Trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress: Seattle Genetics and Astellas announced initial results from a phase 1 clinical trial, EV-103, evaluating enfortumab vedotin in combination with Keytruda (pembrolizumab) in 45 patients with previously untreated locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. The study met outcomes for safety and 71 percent of patients had a confirmed objective response with 93 percent experiencing a reduction in tumor burden.
Expanding Into Earlier Stages of Urothelial Cancer: Seattle Genetics and Astellas expanded the EV-103 trial beyond the metastatic disease setting to include patients with muscle invasive urothelial cancer who are ineligible for cisplatin-based chemotherapy. The additional cohorts will assess single-agent enfortumab vedotin as well as the combination of enfortumab vedotin and pembrolizumab in these patients.
Tucatinib

Tucatinib HER2CLIMB Pivotal Trial Topline Results: The Company announced positive topline results from the HER2CLIMB pivotal trial comparing tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer. Patients had previously received trastuzumab, pertuzumab and ado-trastuzumab emtansine (T-DM1), and 47 percent of the patients enrolled in the trial had brain metastases at the time of enrollment. The trial met the primary endpoint of progression-free survival (PFS). The trial also met two key secondary endpoints at the prespecified interim analysis demonstrating improvement in overall survival and for patients with brain metastases at baseline, the tucatinib arm demonstrated superior PFS. The tucatinib regimen was generally well tolerated with a manageable safety profile. Additional results are scheduled to be presented on December 11 at the 2019 San Antonio Breast Cancer Symposium. The Company plans to submit a New Drug Application (NDA) to the FDA in the first quarter of 2020.
Presented Initial Data from Phase 2 MOUNTAINEER Trial of Tucatinib in HER2-Positive Metastatic Colorectal Cancer at ESMO (Free ESMO Whitepaper) 2019 Congress: Results were presented from the single arm phase 2 clinical trial known as MOUNTAINEER that is evaluating tucatinib in combination with Herceptin (trastuzumab) in patients with HER2-positive, RAS wild-type metastatic colorectal cancer after treatment with first- and second-line standard-of-care therapies. The regimen demonstrated a 52 percent objective response rate and was well tolerated.
Tisotumab Vedotin

Tisotumab Vedotin innovaTV 204 Pivotal Trial Data Expected in 2020: Seattle Genetics and Genmab previously reported the completion of enrollment in the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Topline data from the trial are expected in the first half of 2020.
Ladiratuzumab Vedotin

Initiated Phase 2 Multi-arm Basket Trial: Conducting a phase 2 trial evaluating ladiratuzumab vedotin as monotherapy in select solid tumors with high LIV-1 expression.
THIRD QUARTER AND NINE-MONTHS 2019 FINANCIAL RESULTS

Revenues: Total revenues in the third quarter and nine-month periods ended September 30, 2019 increased to $213.3 million and $626.9 million, respectively, compared to $169.4 million and $480.2 million for the same periods in 2018. Revenues are comprised of the following three components:

Net Product Sales: ADCETRIS net sales for the U.S. and Canada in the third quarter were $167.6 million, a 32 percent increase over net sales of $127.0 million in the third quarter of 2018. Year-to-date ADCETRIS net sales for the U.S. and Canada were $461.6 million, a 34 percent increase over net sales of $344.8 million for the same period in 2018.
Royalty Revenues: Royalty revenues in the third quarter were $27.3 million, compared to $22.7 million in the third quarter of 2018. Royalty revenues were $66.2 million for the year-to-date in 2019, compared to $58.9 million for the same period in 2018. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda, which increased for the periods in 2019 compared to the same periods in 2018.
Collaboration and License Agreement Revenues: Amounts earned under the Company’s ADCETRIS and ADC collaborations were $18.4 million in the third quarter of 2019, compared to $19.8 million for the same period in 2018. Year-to-date collaboration revenues were $99.1 million, a 30 percent increase over collaboration revenues of $76.5 million for the same period in 2018. Collaboration revenues include the earned portion of $42.5 million in milestones achieved year-to-date in 2019. These milestones were based on Takeda’s additional approvals of ADCETRIS in frontline HL and the FDA approval of Genentech’s Polivy (polatuzumab vedotin).
Research and Development (R&D) Expenses: R&D expenses in the third quarter were $196.1 million, compared to $140.2 million in the third quarter of 2018. R&D expenses were $518.3 million for the year-to-date in 2019, compared to $415.5 million for the same period in 2018. The increases reflect additional investment in the Company’s late-stage pipeline, including tucatinib, enfortumab vedotin and tisotumab vedotin, as well as an upfront payment to acquire the rights to a preclinical asset in the third quarter of 2019.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses in the third quarter were $96.1 million, compared to $57.2 million in the third quarter of 2018. SG&A expenses were $258.7 million for the year-to-date in 2019, compared to $181.6 million for the same period in 2018. The increases were primarily attributed to costs to support commercialization efforts related to frontline ADCETRIS indications, launch preparation activities for enfortumab vedotin and the Company’s other late-stage programs as well as higher infrastructure costs to support the Company’s continued growth.

Non-cash, share-based compensation cost for the first nine months of 2019 was $79.7 million, compared to $53.2 million for the same period in 2018.

Net Loss

Net loss for the third quarter of 2019 was $91.9 million, or $0.55 per diluted share, compared to net loss of $67.4 million, or $0.42 per diluted share, for the third quarter of 2018. Net loss in the third quarter of 2019 included a net investment loss of $2.1 million primarily associated with Seattle Genetics’ common stock holdings, which are marked-to-market, compared to a net investment loss of $21.9 million in the third quarter of 2018. For the nine months ended September 30, 2019, net loss was $184.5 million, or $1.13 per share, compared to a net loss of $102.9 million, or $0.66 per share, for the nine months ended September 30, 2018. Net loss for the nine months ended September 30, 2018 included an investment gain of $66.8 million.

Cash and Investments

As of September 30, 2019, cash and investments were $870.3 million, which included net proceeds of approximately $549 million from the Company’s common stock offering in July 2019. In addition, the Company held stock investments valued at $103.6 million.

2019 FINANCIAL OUTLOOK

The Company’s updated financial guidance is detailed below, including updates to its expectations for royalty revenues as well as narrowing its expectations for ADCETRIS net product sales. The Company also updated its R&D expense guidance, primarily due to the acquisition of a preclinical asset in the third quarter and development activities for enfortumab vedotin and tucatinib. Finally, following the positive HER2CLIMB pivotal trial results for tucatinib, the Company expects to initiate launch preparation activities and is updating its guidance for SG&A expenses.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast with supporting slides to discuss its third 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 and available for replay from the Seattle Genetics website at www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 800-353-6461 (domestic) or 334-323-0501 (international). The conference ID is 9057897. A replay of the audio only will be available by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 9057897. The telephone replay will be available until 5:00 p.m. PT on November 1, 2019.