Acorda Second Quarter 2020 Update: Webcast/Conference Call Scheduled for August 4, 2020

On July 28, 2020 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast in conjunction with its second quarter 2020 update and financial results on Tuesday, August 4 at 4:30 p.m. ET (Press release, Acorda Therapeutics, JUL 28, 2020, View Source [SID1234562430]).

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To participate in the Webcast/Conference call, please note there is a new pre-registration process.

To register for the Webcast, use the link below:
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To register for the Conference Call, use the link below:
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**When registering please type your phone number with no special characters**

Once you have registered, you will provided with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 8:30 p.m. ET on August 4, 2020 until 11:59 p.m. ET on September 3, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 5378839. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Karyopharm to Report Second Quarter 2020 Financial Results on August 4, 2020

On July 28, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI) an innovation-driven pharmaceutical company, reported that it will report second quarter 2020 financial results on Tuesday, August 4, 2020 (Press release, Karyopharm, JUL 28, 2020, View Source [SID1234562429]). Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Tuesday, August 4, 2020, to discuss the financial results and other company updates.

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To access the conference call, please dial (877) 870-4263 (local) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

LabCorp Announces 2020 Second Quarter Results

On July 28, 2020 LabCorp (or the Company) (NYSE: LH) reported results for the second quarter ended June 30, 2020 (Press release, LabCorp, JUL 28, 2020, View Source [SID1234562428]).

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"We continue to bring the full power of our combined diagnostics and drug development capabilities against this virus, applying our scientific expertise and ingenuity across all aspects of testing, treatments, and vaccines," said Adam Schechter, chairman and CEO, LabCorp. "During the second quarter, we delivered solid performance across the company despite the impact of the pandemic. I continue to be impressed with how quickly our teams have rallied to confront each and every challenge put before them, and I want to thank our 65,000 employees, as their efforts have been heroic during this difficult time."

Consolidated Results

Second Quarter Results

Revenue for the quarter was $2.77 billion, a decrease of (3.9%) from $2.88 billion in the second quarter of 2019. The decrease in revenue was due to a (5.4%) decline of organic revenue, (0.3%) from the disposition of a business, and (0.1%) from unfavorable foreign currency translation, partially offset by 1.9% from acquisitions. The (5.4%) decline of organic revenue was due to the pandemic, which reduced the Company’s organic Base Business by (20.9%), partially offset by COVID-19 Testing of 15.4%. "Base Business" includes the Company’s business operations except for molecular and serology COVID-19 testing ("COVID-19 Testing"). The decline in organic Base Business includes the lower Medicare and Medicaid pricing as a result of PAMA of (0.5%).

Operating income for the quarter was $297.7 million, or 10.8% of revenue, compared to $335.7 million, or 11.6%, in the second quarter of 2019. The decrease in operating income and margin was primarily due to the reduction in the Base Business (due to the pandemic and ($14.0) million from PAMA) and higher personnel costs (primarily driven by merit increases), partially offset by COVID-19 Testing and LaunchPad savings. The Company recorded restructuring charges, special items, and amortization, which together totaled $83.0 million in the quarter, compared to $111.2 million during the same period in 2019. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $380.7 million, resulting in a 13.8% adjusted operating margin, compared to $446.9 million, or 15.5%, in the second quarter of 2019. The ($66.1) million decline in adjusted operating income and (180) basis point decline in adjusted operating margin were primarily due to the reduction in the Base Business (due to the pandemic) and higher personnel costs, partially offset by the increase in COVID-19 Testing and LaunchPad savings.

Net earnings for the quarter were $231.6 million, compared to $190.4 million in the second quarter of 2019. Diluted EPS were $2.37 in the quarter, an increase of 22.8% over $1.93 in the same period in 2019. The increase in net earnings and diluted EPS in the quarter was primarily due to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Emergency Funding, which increased net earnings and diluted EPS by $55.9 million and $0.42 per share, respectively. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $2.57 in the quarter, a decrease of (12.3%) compared to $2.93 in the second quarter of 2019 due to the pandemic. Adjusted EPS exclude the impact from the CARES Act Emergency Funding.

Operating cash flow for the quarter was $370.7 million, compared to $253.5 million in the second quarter of 2019. The increase in operating cash flow was due to higher cash earnings, partially offset by higher working capital. For the second quarter of 2020, cash earnings included the CARES Act and benefited from income and payroll tax deferrals, while working capital was negatively impacted by an increase in COVID-19 Testing related supplies and accounts receivable. Capital expenditures totaled $98.5 million, compared to $85.2 million a year ago. This increase was driven by expenditures associated with the increase in COVID-19 Testing capacity of $20.1 million. As a result, free cash flow (operating cash flow less capital expenditures) was $272.2 million, up from $168.3 million in the second quarter of 2019.

At the end of the quarter, the Company’s cash balance and total debt were $557.0 million and $6.2 billion, respectively. During the quarter, the Company invested $11.3 million on acquisitions.

Year-To-Date Results

Revenue was $5.59 billion, a decrease of (1.4%) from $5.67 billion in the first half of last year. The decrease in revenue was due to a (3.6%) decline of organic revenue, (0.4%) from the disposition of a business, and (0.1%) from unfavorable foreign currency translation, partially offset by 2.6% from acquisitions. The (3.6%) decline of organic revenue was due to the pandemic, which reduced the Company’s organic Base Business by (11.7%), partially offset by COVID-19 Testing of 8.1%. The decline in the organic Base Business includes the negative impact from PAMA of (0.6%).

Operating income was $105.1 million, or 1.9% of revenue, compared to $653.9 million, or 11.5%, in the first half of 2019. The decrease in operating income and margin was primarily due to the pandemic (including the impairments to goodwill and other assets), higher personnel costs (primarily driven by merit increases and one additional payroll day), and ($33.0) million from PAMA, partially offset by LaunchPad savings. The Company recorded restructuring charges, special items, impairments, and amortization, which together totaled $641.5 million in the first half of 2020, compared to $204.4 million during the same period in 2019. This increase includes COVID-19 related impairments on goodwill and other assets of $437.4 million, or approximately 3.7% of the Company’s total goodwill and intangible assets that the Company recorded in the first quarter of 2020. In addition, the Company recorded $34.0 million of other COVID-19 related costs. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) for the first half of 2020 was $746.6 million, resulting in a 13.3% adjusted operating margin, compared to $858.3 million, or 15.1%, in the first half of 2019. The ($111.7) million decline in adjusted operating income and (180) basis point decline in adjusted operating margin were primarily due to the reduction in the Base Business (due to the pandemic) and higher personnel costs, partially offset by the increase in COVID-19 Testing and LaunchPad savings.

Net losses in the first half of 2020 were ($85.6) million, compared to net earnings of $376.0 million in the first half of 2019. Diluted EPS were ($0.88) in the first half of 2020 compared to $3.79 in the same period in 2019. Net losses and diluted EPS in the first six months of 2020 include the CARES Act Emergency Funding, which improved net losses and diluted EPS by $55.9 million and $0.42 per share, respectively. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $4.94 in the first half of 2020, a decrease of (11.0%) compared to $5.55 in the first half of 2019 due to the pandemic. Adjusted EPS exclude the impact from the CARES Act Emergency Funding.

Operating cash flow was $574.5 million, compared to $419.3 million in the first half of 2019. The increase in operating cash flow was due to higher cash earnings, partially offset by higher working capital. For the first six months of 2020, cash earnings included the CARES Act and benefited from income and payroll tax deferrals, while working capital was negatively impacted by an increase in COVID-19 Testing related supplies and accounts receivable. Capital expenditures totaled $205.1 million, compared to $179.4 million during the same period in 2019. This increase was primarily driven by expenditures associated with the increase in COVID-19 Testing capacity of $22.5 million. As a result, free cash flow (operating cash flow less capital expenditures) was $369.4 million, compared to $239.9 million in the first half of 2019.

Second Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

LabCorp Diagnostics

Revenue for the quarter was $1.69 billion, a decrease of (3.9%) from $1.76 billion in the second quarter of 2019. The decrease in revenue was due to a (4.9%) decline in organic revenue and (0.1%) from unfavorable foreign currency translation, partially offset by 1.1% from acquisitions. The (4.9%) decline in organic revenue was due to a (30.1%) decline of the organic Base Business (due to the pandemic), partially offset by 25.2% from COVID-19 Testing. The (30.1%) decline of the organic Base Business includes a (0.8%) negative impact from PAMA and a (1.2%) reduction due to the September 2019 non-renewal of the BeaconLBS – UnitedHealthcare contract pertaining to the Florida market.

Total volume (measured by requisitions) decreased by (19.5%) as organic volume declined by (20.7%), partially offset by acquisition volume of 1.2%. The decline in organic volume includes a (35.3%) reduction in the Base Business (due to the pandemic), partially offset by increased demand for COVID-19 Testing of 14.6%. The organic Base Business volumes improved throughout the quarter, while at the same time COVID-19 Testing demand continued to grow. For June, daily organic volume increased approximately 6% as compared to the prior year, as the (17%) decline in the organic Base Business was more than offset by COVID-19 Testing volume of approximately 23%. While total volume declined (19.5%), price / mix increased by 15.6% due to COVID-19 Testing of 10.7% and the Base Business of 4.9%. The Base Business price includes the negative impact from PAMA of (0.8%) and the non-renewal of the BeaconLBS contract of (1.2%).

Adjusted operating income for the quarter was $308.8 million, or 18.2% of revenue, compared to $345.4 million, or 19.6%, in the second quarter of 2019. The ($36.6) million decline in adjusted operating income and (140) basis point decline in adjusted operating margin were primarily due to the reduction in the Base Business (due to the pandemic) and higher personnel costs, partially offset by the increase in COVID-19 Testing and LaunchPad savings. The Company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Covance Drug Development

Revenue for the quarter was $1.09 billion, a decrease of (2.9%) from $1.13 billion in the second quarter of 2019. The decrease in revenue was due to a (5.2%) decline in organic revenue, (0.7%) from the disposition of a business, and (0.1%) from unfavorable foreign currency translation, partially offset by a 3.1% benefit from an acquisition. The decline in organic revenue was primarily due to the negative impact from the pandemic, partially offset by a 1.1% increase from molecular COVID-19 testing through its Central Laboratories business. The pandemic continues to cause delays in clinical trial progression and associated testing, reductions in investigator site access, as well as interruptions to the supply chain particularly impacting the nonclinical business unit.

Adjusted operating income for the quarter was $112.7 million, or 10.3% of revenue, compared to $141.7 million, or 12.6%, in the second quarter of 2019. The ($29.0) million decrease in adjusted operating income and (230) basis point decrease in adjusted operating margin were primarily due to the negative impact from the pandemic and higher personnel costs, partially offset by molecular COVID-19 testing and LaunchPad savings. The Company remains on track to deliver approximately $150 million of net savings from its three-year Drug Development LaunchPad initiative by the end of 2020.

Net orders and net book-to-bill during the trailing twelve months were $6.11 billion and 1.32, respectively. Backlog at the end of the quarter was $11.79 billion compared to $11.30 billion last quarter, and the Company expects approximately $4.0 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2020

Given the continued unpredictability pertaining to the COVID-19 pandemic and the corresponding government restrictions and customer behavior, there are a wide-range of feasible financial outcomes. As a result, the Company continues to not provide 2020 guidance. While LabCorp’s Base Business continues to be negatively impacted by the COVID-19 pandemic, the Company’s outlook has improved across the enterprise.

In LabCorp Diagnostics, demand for its Base Business continues to be below the Company’s historical levels; however, this business has been steadily recovering from its trough in April, while at the same time COVID-19 Testing continues to grow. To date, LabCorp has performed more than 8.5 million molecular COVID-19 tests as well as more than 2 million serology COVID-19 tests. The Company’s current molecular COVID-19 testing capacity is approximately 180,000 tests per day and growing.

In Covance Drug Development, while it is expected that the pandemic will continue to negatively impact its business, this impact is expected to subside throughout the year through continuing to work on projects supporting global vaccine and treatment development, with additional support from growth of COVID-19 Testing.

As previously announced, the Company instituted numerous actions to help mitigate the financial impact from the COVID-19 pandemic, which included furloughs, reduced hours, and the suspension of discretionary merit adjustments and 401(k) contributions. In response to LabCorp’s improved outlook, the Company has been resuming regular work schedules and is proceeding with merit adjustments and will retroactively reinstate 401(k) contributions.

Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not

directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the Company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. EDT and is available by dialing 877-898-8036 (720-634-2811 for international callers). The access code is 2597361. A telephone replay of the call will be available through August 11, 2020, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 2597361. A real-time webcast of LabCorp’s quarterly conference call on July 28, 2020, will be available at LabCorp Investor Relations website beginning at 9:00 a.m. EDT. This webcast will be archived and accessible through July 14, 2021.

Chi-Med and Lilly to Collaborate in Commercializing Elunate® in China

On July 28, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) and Eli Lilly and Company ("Lilly") reported an amendment to the 2013 License and Collaboration Agreement on Fruquintinib with Lilly Shanghai, an affiliate of Lilly (Press release, Hutchison China MediTech, JUL 28, 2020, https://www.chi-med.com/chi-med-and-lilly-to-collaborate-in-commercializing-elunate-in-china/ [SID1234562426]). The 2020 Amendment covers the expansion of Chi-Med’s role in the commercialization of Elunate (fruquintinib capsules) in China.

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Under the terms of the 2020 Amendment, Lilly will maintain the exclusive commercialization rights, and as a consequence, will continue to consolidate the sales of Elunate in China. Chi-Med will collaborate with Lilly in commercializing Elunate across China.

In a joint statement, Mr. Christian Hogg, CEO of Chi-Med and Mr. Julio Gay-Ger, President & General Manager, Lilly China, said "After many years of constructive and successful collaboration, Lilly and Chi-Med believe that this agreement now establishes the optimal structure that will allow us to leverage the full resources of both companies to maximize the potential of Elunate in China."

Starting October 1, 2020, Chi-Med will be responsible, through its commercial team in oncology of over 320 staff, for the development and execution of all on-the-ground medical detailing, promotion and local and regional marketing activities in China for Elunate. Lilly and Chi-Med will continue to collaborate, as before, in the formulation and execution of national marketing strategy and events in China for Elunate.

Chi-Med and Lilly will share gross profits linked to sales target performance. Subject to meeting pre-agreed sales targets, Lilly will pay Chi-Med an estimated total of 70% to 80% of Elunate sales in the form of royalties, manufacturing costs and service payments. There is no upfront payment by Lilly or Chi-Med relating to this amendment.

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.

About fruquintinib in metastatic colorectal cancer ("mCRC")
Fruquintinib was approved for marketing by the China National Medical Products Administration ("NMPA") in September 2018 and commercially launched by Lilly in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with mCRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-epidermal growth factor receptor ("EGFR") therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with mCRC in China demonstrating improvement in overall survival, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

In December 2017, Chi-Med initiated a Phase Ib clinical study to evaluate fruquintinib in U.S. patients with advanced solid tumors. Proof-of-concept cohorts in patients with mCRC and metastatic breast cancer were added in 2019 (clinicaltrials.gov identifier: NCT03251378).

Chi-Med is initiating FRESCO-2, a randomized, double-blind, placebo-controlled, multicenter Phase III registration trial in refractory mCRC in the U.S., Europe and Japan. The primary endpoint of the study is overall survival. Over 500 patients will be enrolled from approximately 130 sites in 10 countries. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for development for mCRC patients in June 2020. The FRESCO-2 study design was also reviewed and endorsed by the European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) (clinicaltrials.gov identifier: NCT04322539).

Other Fruquintinib Development
Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. The primary efficacy endpoint is overall survival. In June 2020, Chi-Med completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue (clinicaltrials.gov identifier: NCT03223376).

Immunotherapy combinations: Chi-Med has entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).

Chi-Med’s NDA for Savolitinib in Non-Small Cell Lung Cancer Granted Priority Review in China

On July 28, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that the China National Medical Products Administration ("NMPA") has granted Priority Review status to the New Drug Application ("NDA") for savolitinib for the treatment of non-small cell lung cancer ("NSCLC") with MET Exon 14 skipping mutations (Press release, Hutchison China MediTech, JUL 28, 2020, https://www.chi-med.com/nda-for-savolitinib-in-nsclc-granted-priority-review-in-china/ [SID1234562424]). This is the first NDA filing for savolitinib globally and first for a selective MET inhibitor in China.

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With over 774,000 new cases every year, China accounted for 37% of the world’s annual incidence of lung cancer in 2018.[1] Approximately 80-85% of lung cancer cases are NSCLC.[2] It is estimated that 2-3% of NSCLC patients have MET Exon 14 skipping mutations; these mutations lead to poor prognosis.[3] The annual incidence of MET Exon 14 skipping mutation NSCLC is estimated to be 12,000 to 20,000 in China.

About Priority Review in China
The NMPA’s Priority Review procedure encourages research and development of potential new medicines with clear clinical value, medicines or vaccines that address urgent clinical needs, as well as medicines that address serious infectious diseases, certain rare diseases, and select pediatric conditions or formulations. A potential new medicine may have clear clinical value if it is being developed for serious conditions that are life threatening, debilitating, or impact quality of life. NDAs undergoing Priority Review would receive preferential allocation of NMPA resources during the review process.[4]

About Savolitinib
Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis. Savolitinib has been studied in over 1,000 patients to date. In clinical studies it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

In 2011, Chi-Med entered into a global licensing and joint development and commercialization agreement with AstraZeneca (LSE, STO, NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes NSCLC and kidney cancer, and additional MET-driven tumors are being explored.

Savolitinib development in NSCLC:
Phase II in MET Exon 14 mutation NSCLC (NCT02897479) – In May 2020, data from an ongoing open-label, Phase II registration study was presented as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program ("ASCO 2020"). In patients with MET Exon 14 skipping mutation NSCLC in the efficacy evaluable population, savolitinib demonstrated a 49.2% objective response rate ("ORR"), a 93.4% disease control rate (DCR) and a 9.6 months duration of response (DoR). 36% of patients in the study have pulmonary sarcomatoid carcinoma (PSC), an aggressive subtype of NSCLC. Data were not yet mature for DoR, progression-free survival (PFS) or overall survival ("OS"). Clinical data indicated an acceptable safety profile, with a low adverse event (AE) related discontinuations rate of 14.3%. This data supported the China NDA acceptance in May 2020.

SAVANNAH Phase II study of savolitinib in combination with Tagrisso in patients who have progressed following Tagrisso due to MET amplification or overexpression (NCT03778229) – The SAVANNAH study is a single-arm, open-label study in epidermal growth factor receptor ("EGFR") mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with Tagrisso, an EGFR-tyrosine kinase inhibitor owned by AstraZeneca.

Savolitinib development in kidney cancer:
MET-driven papillary renal cell carcinoma ("RCC") (NCT03091192) – In May 2020, data from 60 patients in the SAVOIR global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at ASCO (Free ASCO Whitepaper) 2020. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients with disease progression at data cut-off, and an encouraging OS hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off. Based on these data, AstraZeneca and Chi-Med are actively evaluating the opportunity to progress clinical work in papillary RCC for monotherapy savolitinib.

CALYPSO Phase II of savolitinib in combination with Imfinzi PD-L1 inhibitor in RCC (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of savolitinib in combination with Imfinzi, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the savolitinib/Imfinzi combination in patients with papillary RCC and clear cell RCC.

Savolitinib development in other cancer indications:
Savolitinib opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including gastric cancer and colorectal cancer.