On May 28, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,reported that filed a lawsuit against Natera, Inc. for false advertising, unfair competition, and unlawful trade practices, relating to misleading statements Natera has made about its own products and the performance of Guardant Health’s new oncology test, Guardant Reveal (Press release, Guardant Health, MAY 28, 2021, View Source [SID1234583276]).

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Guardant Health asked the federal court in San Francisco, California for an injunction preventing Natera from continuing to make these false or misleading statements and requiring Natera to take corrective actions.

Guardant Health’s recent introduction of Guardant Reveal, the first blood-only liquid biopsy test to detect residual and recurrent disease in early-stage cancer survivors, represents an important medical breakthrough for the 1.5 million early-stage colorectal cancer survivors in the U.S.1 Colorectal cancer is the second leading cause of cancer death in the U.S.2 The Guardant Reveal test detects circulating tumor DNA (ctDNA) from a simple blood draw and is performed after surgery to identify patients with residual disease who may benefit most from adjuvant therapy and surveillance. The test can also detect recurrence months earlier than current standard-of-care methods, such as carcinoembryonic antigen tests or imaging.3-8 Guardant Health’s method for ctDNA detection is vastly different from Natera’s Signatera assay, which requires a tissue-biopsy.9

The complaint alleges that Natera is misleading healthcare providers about the performance of the Guardant Reveal test by suggesting the test is inaccurate and/or insensitive, and inferior to Signatera. As a direct result, colorectal cancer patients are missing opportunities for minimal residual disease (MRD) detection and recurrence monitoring, and the attendant benefits of guided treatment decisions.

"Guardant Health believes it is vital that clinicians receive accurate and truthful information, as this impacts potentially life-saving patient treatment decisions. We also believe that companies in the cancer diagnostics business must have patient care as their central mission and should not misrepresent medical science. When they do, we believe that immediate corrective action is required," said John Saia, Senior Vice President, General Counsel and Corporate Secretary at Guardant Health.

On May 28, 2021 Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, reported the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors (Press release, Fennec Pharmaceuticals, MAY 28, 2021, View Source [SID1234583262]).

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The resubmission for PEDMARK follows receipt of final minutes from a Type A meeting with the FDA. Importantly, the Complete Response Letter (CRL) received on August 10, 2020 referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.

"We are pleased to have resubmitted the NDA for PEDMARKTM and look forward to working with the FDA through the review process," said Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals, Inc. "We remain committed to reducing the risk of life-long hearing loss for children receiving cisplatin chemotherapy. If approved, PEDMARK stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients."

About PEDMARK

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK received Breakthrough Therapy and Fast Track Designation from the FDA in March 2018.

On May 28, 2021 NEC Corporation (NEC; TOKYO: 6701) reported the development of an AI technology for supporting doctors to detect neoplasia in Barrett’s esophagus during endoscopic procedures (Press release, NEC, MAY 28, 2021, View Source [SID1234583277]). This is the world’s first technology of its kind to comply with the requirements for CE mark labeling, a European safety, health and environmental protection standard (*1), and is being released as WISE VISION Endoscopy, where it will soon be available in Europe to help doctors in the detection of Barrett’s neoplasia (*2).

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This software is connected to endoscopy processors and automatically notifies users of potential Barrett’s neoplasia from images captured during endoscopic procedures.

Barrett’s esophagus is a pre-cancerous condition in which the inner lining of the esophagus is replaced by a lining that resembles that of the stomach. Patients with Barrett’s esophagus have 30-40 fold higher risk of developing cancer of the esophagus as compared to the normal population (*3).

However, if this cancer can be detected at an early stage, then it can be removed through the endoscope and a patient can be cured.

To help resolve this issue, NEC collaborated with Professor Pradeep Bhandari (Portsmouth, UK), Chair of the European Society of Gastrointestinal Endoscopy (ESGE) Research Committee, in development of this new technology to support doctors to detect Barrett’s neoplasia during examination. In developing this solution, NEC applied its face recognition technology that has been highly evaluated (*4) by the National Institute of Standards and Technology (NIST) in the United States, and belongs to NEC’s portfolio of cutting-edge AI technologies, "NEC the WISE."

"I am delighted that NEC, as one of the world’s leaders in AI technology, has entered the field of endoscopy and developed WISE VISION Endoscopy to detect and help manage Gastrointestinal neoplasia," said Professor Pradeep Bhandari, Chair of the ESGE Research Committee.

On May 28, 2021 Amgen (NASDAQ: AMGN) reported that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy (Press release, Amgen, MAY 28, 2021, View Source [SID1234583263]). LUMAKRAS has received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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"The FDA approval of LUMAKRAS is a breakthrough moment for patients with KRAS G12C-mutated non-small cell lung cancer because there is now a targeted therapy for this common, but previously elusive, mutation," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "KRAS has challenged cancer researchers for more than 40 years with many deeming it as ‘undruggable.’ The LUMAKRAS development program was a race against cancer for Amgen’s scientists and clinical trial investigators who together have now successfully delivered this new medicine to patients in less than three years—from first patient dosed to U.S. regulatory approval."

The FDA approval of LUMAKRAS is based on results from a subset of patients in CodeBreaK 100, the largest clinical trial conducted to date exclusively for patients with the KRAS G12C mutation. The trial demonstrated favorable efficacy and tolerability in 124 patients with KRAS G12C mutation-positive NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy. In the trial, 960 mg of LUMAKRAS administered orally once-daily demonstrated an ORR (a proportion of patients with ≥ 30% decrease in tumor) of 36% (95% CI: 28-45) with 81% (95% CI: 73-87) of patients achieving disease control (percentage of patients who have achieved complete response, partial response and stable disease for more than three months). The median DoR was 10 months. The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough. Adverse reactions resulting in permanent discontinuation of LUMAKRAS occurred in 9% of patients.

"Sotorasib represents a major advancement in oncology and changes the treatment paradigm for patients with KRAS G12C-mutated non-small cell lung cancer," said Bob T. Li, M.D., Ph.D., MPH, principal investigator at Memorial Sloan Kettering Cancer Center. "Patients with non-small cell lung cancer who have progressed beyond first-line treatment face a poor prognosis and have limited treatment options available to them. Sotorasib delivers a new option for these patients, and it is the first KRAS-targeted therapy to be approved after nearly four decades of research."

NSCLC accounts for approximately 84% of the 2.2 million new lung cancer diagnoses each year worldwide, including approximately 236,000 new cases in the U.S.2,3 KRAS G12C is one of the most prevalent driver mutations in NSCLC, with about 13% of patients with non-squamous NSCLC in the U.S. having the KRAS G12C mutation.1

Amgen’s Commitment to Comprehensive Biomarker Testing and Patient Support
About half of all patients with NSCLC harbor a targetable driver mutation, yet despite the integral role that biomarkers play in identifying patients who may benefit from targeted therapies, many patients are not tested.4,5

Amgen has partnered with two companies—Guardant Health and QIAGEN—to develop blood- and tissue-based companion diagnostics (CDx), respectively, for LUMAKRAS. With the addition of these tests, patients and clinicians will have more options and flexibility for conducting KRAS G12C biomarker testing.

"Biomarker testing for patients with non-small cell lung cancer is critical because it informs a patient’s treatment path with a personalized and tailored approach. The only way to identify the KRAS G12C mutation is to test for it, so I urge patients to ask their care teams about comprehensive biomarker testing. It is important that patients and their healthcare providers know that KRAS G12C is now an actionable mutation," said Andrea Ferris, president and CEO of LUNGevity. "Today’s FDA approval of a therapy targeted for KRAS G12C, one of the most prevalent biomarkers in non-small cell lung cancer, brings hope to the many patients who carry this mutation and is a significant moment for the lung cancer community who need more innovative treatment options."

Amgen is committed to supporting patients with NSCLC and to helping appropriate patients with affordable access to LUMAKRAS. Patients, caregivers and physicians who need support, tools or resources can contact Amgen Assist360(1-888-4ASSIST). Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including free medicines through the Amgen Safety Net Foundation for qualifying individuals with no or limited drug coverage.

Amgen to Webcast Investor Call on LUMAKRAS FDA Approval
Amgen will host a webcast call for the investment community on Tuesday, June 1, 2021 at 5 a.m. PT / 8 a.m. ET. David M. Reese, M.D., executive vice president of Research and Development and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will participate to discuss the recent FDA approval of LUMAKRAS.

Live audio of the investor call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

About LUMAKRAS (sotorasib)
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRASG12C inhibitor.6 LUMAKRAS was the first KRASG12C inhibitor to enter the clinic and is being studied in the largest clinical program exploring 11 combinations with global investigator sites spanning five continents.

LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced and metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. As part of the evaluation for this accelerated approval, FDA is requiring a post-marketing trial to investigate whether a lower dose will have a similar clinical effect.

LUMAKRAS is also being studied in multiple other solid tumors.6

In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen submitted a Marketing Authorization Application (MAA) in the EU in December 2020 and New Drug Applications in Japan (J-NDA) and Switzerland in April 2021. Additionally, Amgen submitted MAAs for sotorasib in Australia, Brazil, Canada and the United Kingdom in January 2021 to participate in the FDA’s Project Orbis initiative. Sotorasib was granted Breakthrough Therapy Designation in the U.S. and China.

LUMAKRAS (sotorasib) U.S. Indication
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

LUMAKRAS (sotorasib) Important Safety Information

Hepatotoxicity

LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
Monitor liver function tests (ALT, AST, and total bilirubin) prior to the start of LUMAKRAS, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
Withhold, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.
Interstitial Lung Disease (ILD)/Pneumonitis

LUMAKRAS can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS in CodeBreaK 100 ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS was discontinued due to ILD/pneumonitis in 0.6% of patients.
Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions

The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
Drug Interactions

Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS.
If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS 4 hours before or 10 hours after a locally acting antacid.
Please see LUMAKRAS full Prescribing Information.

About Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined.3 Overall survival rates for NSCLC are improving, but remain poor for patients with advanced disease and 5-year survival is only 7% for those with metastatic disease.7

KRAS G12C is the most common KRAS mutation in NSCLC.8 In the U.S., about 13% of patients with non-squamous NSCLC harbor the KRAS G12C mutation.1 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with current therapies are suboptimal with a median progression-free survival of approximately 4 months following second-line treatment of KRAS G12C-mutated NSCLC.9

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected later in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment.

About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That’s why we’re relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we’re advancing oncology at the speed of life.

On May 28, 2021 EQRx, a company committed to developing and delivering important new medicines at lower prices, along with its partner CStone Pharmaceuticals, reported that the Phase 3 study evaluating sugemalimab, an anti-PD-L1 antibody, in Stage III NSCLC met its primary endpoint of prolonged progression-free survival (Press release, EQRx, MAY 28, 2021, View Source [SID1234583278]). These results were disclosed after a planned interim analysis of GEMSTONE-301, a study investigating sugemalimab as consolidation therapy in patients with locally advanced, unresectable Stage III NSCLC without disease progression after either concurrent or sequential chemoradiotherapy. These findings, which were statistically significant and clinically meaningful, were determined by Blinded Independent Central Review (BICR) based on RECIST v1.1. Sugemalimab was well-tolerated and no new safety signals were observed. In stratified subgroup analyses, sugemalimab was associated with clinical benefit regardless of whether patients received concurrent or sequential chemoradiotherapy prior to sugemalimab.

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"Stage III NSCLC represents a heterogeneous group of patients with a wide range of therapeutic outcomes. Around the world, both sequential and concurrent chemotherapy are commonly used treatment approaches for this stage of disease"

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Positive results were previously reported on the use of sugemalimab in Stage IV NSCLC at ESMO (Free ESMO Whitepaper) Asia 2020, demonstrating that sugemalimab plus standard-of-care chemotherapy prolonged PFS and was well-tolerated compared to chemotherapy regardless of PD-L1 expression level or histology. Together, these two positive Phase 3 studies position sugemalimab as a potential treatment option to address both Stage III and IV NSCLC.

"Stage III NSCLC represents a heterogeneous group of patients with a wide range of therapeutic outcomes. Around the world, both sequential and concurrent chemotherapy are commonly used treatment approaches for this stage of disease," said Vincent Miller, M.D., physician-in-chief at EQRx. "These encouraging results from both the Stage III and Stage IV studies suggest sugemalimab is a promising potential treatment option in a broad range of patient populations."

"The PD(L)1 market is becoming more crowded, but the constant debate around pricing without action is to the detriment of patients. EQRx was created to address this challenge head-on by bringing high-quality medicines to patients at much lower prices," commented Alexis Borisy, chief executive officer of EQRx. "PD(L)1 therapies are the backbone of cancer treatment, and we see tremendous opportunity for sugemalimab as a monotherapy or in combination regimens, lowering the overall costs of immunotherapy options."

Specific study data will be presented at an upcoming medical conference.

EQRx and CStone Pharmaceuticals have partnered to expand global access to sugemalimab. The Companies plan to pursue regulatory discussions in multiple countries.

ABOUT LUNG CANCER

Every 15 seconds, a person across the world is diagnosed with lung cancer, and every 18 seconds, a person dies of the disease, making it the most commonly diagnosed cancer and the leading cause of cancer death worldwide. Lung cancer is the second most commonly diagnosed cancer worldwide. In 2020, an estimated 2.2 million people were diagnosed with lung cancer.1 NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses.

GEMSTONE-301 STUDY

GEMSTONE-301 study is a multicenter, randomized, double-blind Phase 3 clinical trial (clinicaltrials.gov registration number: NCT03728556; drug clinical trial registration number: CTR20181429), being conducted in China to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with locally advanced/unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. The study’s primary endpoint was PFS as assessed by BICR according to RECIST v1.1; the secondary endpoints included overall survival, PFS as assessed by the investigators and safety.

GEMSTONE-302 STUDY

GEMSTONE-302 (clinicaltrials.gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) is a randomized, double-blind, Phase 3 study of anti-PD-L1 monoclonal antibody sugemalimab plus platinum-based chemotherapy as first-line treatment for Stage IV squamous or non-squamous NSCLC to evaluate the efficacy and safety of sugemalimab combined with chemotherapy vs. placebo combined with chemotherapy in first-line treatment naïve patients with Stage IV NSCLC. The study was conducted in China and the primary endpoint was investigator-assessed PFS. Secondary endpoints included overall survival, BICR-assessed PFS and safety.

In August 2020, the GEMSTONE-302 study met its primary endpoint and data was presented at ESMO (Free ESMO Whitepaper) Asia 20202, demonstrating that sugemalimab in combination with chemotherapy significantly prolonged PFS and reduced the risk of disease progression or death by 50% compared to placebo in combination with chemotherapy, as assessed by iDMC at the planned interim analysis. Subgroup analysis showed clinical benefit regardless of PD-L1 expression level or pathologic subtype in patients with Stage IV NSCLC. Sugemalimab in combination with chemotherapy was well tolerated, no new safety signals were identified. In November 2020, the National Medical Products Administration (NMPA) of China accepted the New Drug Application for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer patients.

ABOUT SUGEMALIMAB

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduce the risk of immunogenicity and potential toxicities in patients, a potential advantage during treatment.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase 1 study in the U.S., the clinical program in China includes one Phase 2 registration study for lymphoma (CS1001-201) and four Phase 3 registration studies in Stage III NSCLC, Stage IV NSCLC, gastric cancer, and esophageal cancer.

CS1001-201 is a single-arm, multicenter, Phase 2 pivotal study designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). Based on the encouraging preliminary efficacy results, sugemalimab was granted Orphan Drug Designation for the treatment of T-cell lymphoma and Breakthrough Therapy Designation for the treatment of R/R ENKTL by the U.S. Food and Drug Administration. It has also been granted Breakthrough Therapy Designation by the NMPA of China. The proposed indication is R/R ENKTL.

EQRx holds the development and commercialization rights to sugemalimab outside of Greater China.