On November 1, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) and AstraZeneca PLC ("AstraZeneca") (LSE/STO/Nasdaq: AZN) reported that they have initiated SAMETA, a global Phase III study of savolitinib (ORPATHYS in China), an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, in combination with AstraZeneca’s PD-L1 inhibitor IMFINZI (durvalumab) in patients with MET-driven advanced papillary renal cell carcinoma ("PRCC") (Press release, Hutchison China MediTech, NOV 1, 2021, View Source [SID1234593986]). The first patient received their first dose on October 28, 2021.

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The Phase III trial is an open-label, randomized, controlled study in treatment-naïve patients with MET-driven, unresectable and locally advanced or metastatic PRCC, to evaluate the efficacy and safety of savolitinib in combination with IMFINZI, compared to single agent IMFINZI or single agent SUTENT (sunitinib), an oral multi-kinase inhibitor considered the standard-of-care treatment option in PRCC. The primary endpoint of the study is median progression free survival ("PFS"). Other endpoints include median overall survival ("OS"), objective response rate ("ORR"), duration of response ("DoR"), 6-months and 12-months disease control rate ("DCR"), time to second progression (PFS2), safety, pharmacokinetics ("PK") and quality of life. Additional details may be found at clinicaltrials.gov, using identifier NCT05043090.

About PRCC
PRCC is a subtype of kidney cancer that is unusually difficult to treat, with low response rates from current treatment options and no treatments approved for patients with tumors that harbor MET-driven alterations. Worldwide, about 430,000 new patients were diagnosed with kidney cancer in 2020[1]. In the US, an estimated 76,000 people will be diagnosed with kidney cancer in 2021[2]. Approximately 90% of kidney tumors are renal cell carcinoma ("RCC"), which consist of several heterogeneous subtypes with highly variable clinical courses and outcomes[3],[4]. PRCC accounts for up to 15% of RCC[4],[5]. The MET gene has been found to be a major chromosome-level alteration in 81% of type-1 PRCC and 46% of type-2 PRCC, or 63% of PRCC[6].

About Savolitinib (ORPATHYS in China)
Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor ("TKI") that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS for the treatment of patients with non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

Savolitinib development in NSCLC
Phase II study of savolitinib monotherapy in MET Exon 14 skipping alteration NSCLC (NCT02897479) – In June 2021, savolitinib was granted drug registration conditional approval by the National Medical Products Administration of China (NMPA) for MET Exon 14 skipping alteration NSCLC. The approval was based on the results of a Phase II study in China; results of this study were published in The Lancet Respiratory Medicine[7]. At a median follow up of 17.6 months, savolitinib demonstrated an ORR of 42.9% (95% confidence interval [CI] 31.1-55.3) and median PFS of 6.8 months (95% CI 4.2-9.6) in the overall trial population. DCR in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of savolitinib was consistent with previous trials, and no new safety signals were identified. Continued approval is contingent upon the successful completion of a confirmatory trial in this patient population (NCT04923945).

TATTON Phase Ib/II expansion studies of savolitinib in combination with TAGRISSO in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT02143466) – This global exploratory study in over 220 EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI. Results were published in Lancet Oncology[8] and final analysis was presented at the World Conference on Lung Cancer[9]. Three cohorts with patients treated following progression on first- or second-generation EGFR TKI demonstrated an ORR of 64.7-66.7% and a median PFS of 9.0-11.1 months. The cohort of patients treated following progression on a third-generation EGFR TKI demonstrated an ORR of 33.3% (95% CI 22.4-45.7), with a median PFS of 5.5 months (95% CI 4.1-7.7). The combination demonstrated encouraging anti-tumor activity and an acceptable risk-benefit profile.

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

SACHI Phase III study of savolitinib in combination with TAGRISSO in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT05015608) – This is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.

SANOVO Phase III study of savolitinib in combination with TAGRISSO in treatment-naïve patients with EGFR mutant positive NSCLC with MET overexpression (NCT05009836) – This is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.

Savolitinib development in kidney cancer
SAVOIR randomized, controlled study of savolitinib monotherapy in MET-driven PRCC (NCT03091192) – In May 2020, data from 60 patients in this global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO (Free ASCO Whitepaper) 2020 Program and published simultaneously in JAMA Oncology[10]. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients experiencing 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.

CALYPSO Phase I/II study 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. An analysis of 41 patients enrolled in the PRCC cohort of in this study was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting[11], showing a confirmed response rate in 8 out of the 14 MET-driven patients, or 57%, with a median DoR of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.

SAMETA Phase III study in combination with IMFINZI PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC (NCT05043090) – Based on the encouraging results of the SAVOIR and CALYPSO studies, we have initiated SAMETA, a global Phase III, open-label, randomized, controlled study of savolitinib plus IMFINZI versus sunitinib monotherapy versus IMFINZI monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic papillary RCC.

Savolitinib development in gastric cancer
Phase II study of savolitinib monotherapy in advanced or metastatic MET amplified gastric cancer ("GC") or adenocarcinoma of the gastroesophageal junction ("GEJ") (NCT04923932) – This is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and PK of savolitinib in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy.

This trial follows multiple Phase II studies that have been conducted in Asia to study savolitinib in MET-driven GC patients, including VIKTORY[12]. VIKTORY is an investigator initiated Phase II umbrella study in GC in South Korea in which a total of 715 patients were successfully sequenced into molecular-driven patient groups, including those with MET amplified GC. Patients whose tumors harbor MET amplification were treated with savolitinib monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).

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 colorectal cancer.

About IMFINZI
IMFINZI (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with PD-1 and CD80 proteins, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

IMFINZI is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy and is the global standard of care in this setting based on the PACIFIC Phase III trial.

IMFINZI is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer ("SCLC") based on the CASPIAN Phase III trial.

IMFINZI is also approved for previously treated patients with advanced bladder cancer in several countries. Since the first approval in May 2017, more than 100,000 patients have been treated with IMFINZI.

As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, SCLC, bladder cancer, liver cancer, biliary tract cancer, esophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumors.

On November 1, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2021 (Press release, Corvus Pharmaceuticals, NOV 1, 2021, View Source [SID1234594008]).

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"Corvus is a leader in the development of precisely targeted therapies targeting the adenosine pathway. This includes mupadolimab, our anti-CD73 antibody, and ciforadenant, our small molecule antagonist of the adenosine A2A receptor," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We continue to advance mupadolimab with a focus on non-small cell lung cancer (NSCLC) and HPV positive (human papilloma virus) head and neck cancers (HNSCC). Two expansion cohorts in our Phase 1b/2 trial are enrolling patients with these tumors and we are evaluating treatment with a combination of mupadolimab and pembrolizumab. We believe mupadolimab is well positioned to potentially improve patient outcomes based on its mechanism of inhibiting immunosuppressive adenosine in the tumor microenvironment and by enhancing immune responses to the tumor. Its novel immune enhancing properties are based on its known B cell stimulating activities, which have been observed in our cancer and COVID-19 clinical trials. We also continue to expand our other oncology programs, including with our Chinese partner, Angel Pharmaceuticals, who recently received an IND approval notice in China to initiate Phase 1/1b clinical development of CPI-818 for the treatment of T cell lymphomas."

2021 Key Areas of Focus
The Company is efficiently advancing its clinical programs – mupadolimab, CPI-818 and ciforadenant – along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:

Mupadolimab for NSCLC and Head and Neck Cancer

The Company has completed enrollment of patients with NSCLC and Head and Neck Cancer in its Phase 1/1b clinical trial of mupadolimab monotherapy; combination with ciforadenant, Corvus’ small molecule inhibitor of the A2A receptor; combination with pembrolizumab; or triplet combination with ciforadenant and pembrolizumab. We anticipate that the results will be presented at the annual meeting of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2021.
Mupadolimab for HPV+ Oropharyngeal Cancer of the Head and Neck

The Company is enrolling a Phase 1b/2 clinical trial in patients with HPV+ oropharyngeal cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the clinical trial is response rate and initial results are anticipated in 2022.
Mupadolimab for NSCLC

In September 2021, the Company began enrolling patients in a Phase 1b/2 clinical trial in patients with relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the trial is response rate and results are anticipated to be reported in 2022.
Mupadolimab for Viral Associated Cancers and Viral Diseases

The Company is evaluating mupadolimab in other viral associated tumors such as cancer of the cervix and head and neck cancers caused by Epstein Barr virus (EBV), which is a member of the herpes virus family and one of the most common human viruses.
The Company is evaluating partnership opportunities to continue the development of mupadolimab as a therapeutic for the treatment of COVID-19. We believe this approach is supported by results from the Company’s discontinued Phase 3 randomized, double blind placebo-controlled clinical trial of mupadolimab for hospitalized patients with COVID-19, which were published in September. The primary endpoint of the clinical trial was the proportion of patients progressing to respiratory failure or death during the 28 days after dosing with either mupadolimab 2mg/kg, 1mg/kg or placebo. Forty patients were enrolled in the clinical trial prior to its voluntary discontinuation. In the 2mg/kg cohort, 93.3% of patients were alive and free from respiratory failure, compared to 85.7% in the 1mg/kg cohort and 81.1% in the placebo cohort. In addition, positive trends favoring mupadolimab treatment compared to placebo were seen for all the key secondary endpoints, including time to clinical improvement, time to sustained clinical improvement and time to hospital discharge. Due to the number of participants enrolled in the trial before it was discontinued, the foregoing results were not sufficiently powered for statistical significance.
CPI-818 Phase 1/1b Clinical Trial for T cell Lymphoma in Partnership with Angel Pharmaceuticals

The Company’s ongoing Phase 1/1b trial with CPI-818 has been expanded to enroll patients with certain types of T cell leukemias in addition to T cell lymphomas.
The Company’s partner in China, Angel Pharmaceuticals, plans to initiate a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas, with the potential to expand into autoimmune diseases over time. In October, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approved Angel’s IND for CPI-818 and the trial is expected to open by early 2022. Angel Pharmaceuticals will be responsible for all expenses related to executing the trial in China.
Ciforadenant Phase 2 Clinical Trial for Front Line RCC

In addition to developing mupadolimab for blocking adenosine production, the Company is developing Ciforadenant, a small molecule antagonist of the adenosine A2A receptor. It is designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. The Company also discovered the Adenosine Gene Signature, which has demonstrated the potential to serve as a biomarker to identify patients most likely to respond to treatment with ciforadenant.
The Company plans to collaborate with the Kidney Cancer Consortium to initiate a Phase 2 clinical trial of ciforadenant in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and another approved therapeutic agent for RCC. The clinical trial is expected to enroll up to 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies and data from earlier clinical trials with ciforadenant indicate adenosine may be a cause of resistance to current therapies with anti-PD(L)-1. Tumor biopsies will be evaluated for expression of the Adenosine Gene Signature.
Financial Results

As of September 30, 2021, Corvus had cash, cash equivalents and marketable securities totaling $76.3 million as compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $32.0 million resulted from the receipt of approximately $32 million in net proceeds from the sale of the Company’s common stock through an underwritten offering, approximately $29 million in net proceeds from the Company’s at the market equity offering program, and approximately $1 million in proceeds from the exercise of common stock options and was reduced by approximately $30 million of cash used in operating activities in the nine months ended September 30, 2021. Consistent with last quarter, Corvus expects full year 2021 net cash used in operating activities to be approximately $36 million, resulting in a projected balance of cash, cash equivalents and marketable securities of approximately $70 million at December 31, 2021.

Research and development expenses for the three months ended September 30, 2021 totaled $7.0 million compared to $6.6 million for the same period in 2020. The increase of $0.4 million was primarily due to an increase in clinical trial costs.

The net loss for the three months ended September 30, 2021 was $10.7 million compared to a net loss of $9.8 million for the same period in 2020. Total stock compensation expense for the three months ended September 30, 2021 was $1.1 million compared to $1.3 million for the same period in 2020.

On November 1, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will host a virtual "Spotlight Event" on Wednesday, November 10, 2021 at 11:00 a.m. Eastern Time (Press release, UroGen Pharma, NOV 1, 2021, View Source [SID1234594025]). The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC), and the Company’s earlier-stage clinical programs including UGN-301 and UGN-302.

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In addition to presentations from UroGen’s Chairman Arie Belldegrun, M.D. and members of the Company’s senior management team, the program will include a Key Opinion Leader panel discussion on the treatment of NMIBC.

Please register for the webinar on the Company’s website at www.urogen.com under the Events & Presentations section of the Investor Relations site (View Source).

Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Third Quarter 2021 Financial Results

Additionally, the Company announced that it will report third quarter 2021 financial results on Monday, November 15, 2021, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

The webcast will be available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for 30 days.

On November 1, 2021 Epizyme reported the launch of In My Blood, an online resource designed to empower people living with follicular lymphoma to partner with their healthcare providers and play a proactive role in treatment decision-making based on where they are in their follicular lymphoma journey (Press release, Epizyme, NOV 1, 2021, View Source [SID1234594042]).

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In My Blood offers follicular lymphoma patients, and their care partners, unique resources to aid them in taking a proactive role in their care as they navigate life with this typically incurable blood cancer. A central feature is My Follicular Lymphoma Coach, a first-of-its-kind quiz for follicular lymphoma patients. This brief questionnaire takes key information into consideration, including stage of disease, current symptoms, and lifestyle. Patients are then provided with a customized, downloadable guide to support them in having proactive, informed discussions with their healthcare providers. The personalized guide is designed for patients at any stage of their experience with follicular lymphoma and provides tools for them to engage proactively in their health, during both periods of treatment and remission.

"Over the years, through continued partnership with healthcare providers and patient advocates in the follicular lymphoma community, we’ve seen firsthand the importance of the healthcare provider-patient relationship when dealing with the complexities of navigating this typically incurable blood cancer over many years, sometimes even decades," said Cheya Pope, Vice President, Corporate Affairs at Epizyme. "Knowing this relationship is paramount, we created In My Blood and My Follicular Lymphoma Coach, with input from the follicular lymphoma advocacy community, to fulfill a need for patients. We hope the resources provided will enable meaningful conversations between patients and healthcare providers to ultimately improve care."

As clear and proactive communication with healthcare providers is essential in order to detect signs of a potential relapse in follicular lymphoma, In My Blood also offers downloadable daily and weekly symptom trackers to support patients and care partners with disease monitoring. It also features stories and insights from individuals living with follicular lymphoma, which highlight how they have been able to proactively manage their disease and celebrates how they continue living life to the fullest. Additional resources, background information and links to related advocacy organization resources are also available.

"Upon learning you have follicular lymphoma the sheer volume of information, choices, and decisions you have to make can feel overwhelming. When I was newly diagnosed, I knew that I would need to advocate for myself to ensure that I received the best care and treatment based on my diagnosis and individual needs," said Kendra Munger, In My Blood patient ambassador. "Now with In My Blood and My Follicular Lymphoma Coach, patients like me who are navigating life with follicular lymphoma can create a personalized guide with relevant information for where they are in their follicular lymphoma journey, along with important questions to ask their doctors as they work together to determine the best path forward."

For more information on In My Blood and to access My Follicular Lymphoma Coach, visit FollicularLymphoma.com.

About Follicular Lymphoma

Follicular lymphoma is a type of cancer that starts in the lymphatic system, a system of lymph nodes found throughout the body.i Of the estimated 74,000 individuals diagnosed with non-Hodgkin’s lymphoma in the United States each year, follicular lymphoma accounts for approximately 20% of all cases, or about 14,800 individuals.ii People with follicular lymphoma often experience periods of remission before the disease returns (relapse), and they typically undergo treatment with numerous therapies during their disease journey. In addition, many patients find their cancer has become resistant to treatments they’ve received before, leaving them with fewer options when their cancer returns. To learn more about follicular lymphoma and In My Blood, visit FollicularLymphoma.com.

On November 1, 2021 Lab Genomics, a personalized medicine company providing state of the art molecular genetic testing in Southern California and other US locations, reported in partnership with Canexia Health that MolDX has finalized coverage determination under the policy "Plasma-Based Genomic Profiling in Solid Tumors” for Follow It, a circulating tumor DNA (ctDNA) assay (Press release, Lab Genomics, NOV 1, 2021, View Source [SID1234594058]). The coverage decision provides Medicare reimbursement for Follow It for use in breast, lung, and colorectal cancers.

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Follow It, which requires only a simple blood draw from patients, analyzes ctDNA in plasma to evaluate somatic mutations in 337 hotspots and 26 exons in 38 cancer associated genes. This information can be used to guide targeted treatment selection, which has been shown to improve patient outcomes up to threefold.

"Medicare coverage for liquid biopsy is a critical step in helping cancer patients gain access to targeted therapies," said Leena Dalal, Founder of Lab Genomics. "We commend MolDX for this decision that supports our focus on delivering individualized medical care."

"Reimbursement for Follow It greatly expands access to a minimally-invasive test for cancer treatment selection for some of the most prevalent forms of solid tumor cancer," said Michael Ball, CEO of Canexia Health. "This MolDX decision marks a significant milestone in our mission to transform cancer care."