On November 9, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported data from the ongoing Phase 2 clinical trial of mocetinostat in combination with durvalumab (IMFINZI) in non-small cell lung cancer (NSCLC) patients at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C (Press release, Mirati, NOV 9, 2018, View Source [SID1234531095]). The data will be presented today in a poster and also in an oral presentation on Sunday, November 11th.

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Highlights from the Oral Presentation

The clinical trial is a Phase 2 study evaluating the efficacy and safety of mocetinostat in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with NSCLC who have experienced documented disease progression following prior treatment with an immune checkpoint inhibitor. As of the data cut-off date of October 2, 2018:

29 patients were evaluable for response with at least one radiographic scan. Patients had a median of two lines of previous therapy.
12/29 evaluable patients demonstrated tumor reductions.
6/29 evaluable patients demonstrated tumor reductions of greater than 30%.
5/29 evaluable patients achieved a confirmed Partial Response (PR).
4/29 evaluable patients, including 2 responding patients, remained on treatment at the time of data cut-off.
A preliminary Kaplan-Meier estimate of median duration of response was greater than 5 months.
The combination has been well-tolerated and most adverse events (AEs) were grade 1 or 2.
"The combination of mocetinostat with durvalumab demonstrated clinical benefit in this difficult to treat population of checkpoint inhibitor refractory NSCLC patients," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer at Mirati Therapeutics. "While these results are promising, we have made the strategic portfolio decision to prioritize sitravatinib for further development in the treatment of checkpoint inhibitor refractory patients and plan to explore collaborative opportunities to further develop mocetinostat."

The Company recently announced plans to initiate a Phase 3 clinical trial comparing sitravatinib in combination with checkpoint inhibitor therapy to docetaxel in second line checkpoint inhibitor refractory NSCLC patients in the first half of 2019. In addition, the Company also announced plans to initiate a Phase 1/2 clinical trial of MRTX849, an oral inhibitor of KRAS G12C, in patients with NSCLC, colorectal cancer, and other solid tumors that harbor the G12C mutation. Trial initiation is planned for early 2019 after the investigational new drug (IND) allowance letter is received from the U.S. Food and Drug Administration (FDA) for the application that was filed in October 2018.

About Mocetinostat

Mocetinostat is an oral, Class I and IV selective histone deacetylase (HDAC) inhibitor. Inhibition of histone acetylation is predicted to enhance the recognition of tumor cells by anti-tumor T cells and reverse immunosuppressive factors in the tumor microenvironment. Mocetinostat is being evaluated in a Phase 2 clinical trial in combination with durvalumab (IMFINZI) in non-small cell lung cancer (NSCLC) patients who have experienced disease progression following prior treatment with a checkpoint inhibitor.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.

About MRTX849

MRTX849 is an orally-available small molecule that potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MTRX849 has demonstrated broad-spectrum tumor regression in a large cohort of KRAS G12C positive, pre-clinical in-vivo human tumor models. MRTX849 demonstrated complete regression of tumors in a subset of models at well-tolerated dose levels. Early proof-of-concept clinical data is anticipated in 2019.

On November 9, 2018 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported a business update and financial results for the third quarter ended September 30, 2018 (Press release, Leap Therapeutics, NOV 9, 2018, View Source [SID1234531197]).

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"Our team has executed extremely well over the past quarter, rapidly enrolling multiple clinical trials and presenting impressive clinical and preclinical data for both of our programs. We are excited about the potential for our DKN-01 antibody in patients with esophagogastric cancer, both in combination with KEYTRUDA (pembrolizumab) and with paclitaxel. We believe that the emerging response and disease control rates, and now the progression-free survival and overall survival data, reflect outcomes that are clinically meaningful to patients with very difficult to treat cancer and are greater than what has previously been demonstrated with approved single agents," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we look forward to presenting data from the studies of our TRX518 antibody in combination with KEYTRUDA, OPDIVO (nivolumab) or gemcitabine at the European Society for Molecular Oncology 2018 Immuno-Oncology Congress in December."

Recent Developments

Since the end of the second quarter, the Company has continued to make strong progress with the development of their product candidates.

DKN-01/KEYTRUDA: At the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) 2018 Annual Congress, Leap presented clinical data from a study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. As of the cut-off date for the poster, DKN-01 and pembrolizumab had a 23.5% overall response rate and 58.8% disease control rate in evaluable gastric or gastroesophageal junction cancer patients who have been heavily pre-treated and not received any prior anti-PD-1/PD-L1 therapy. All four of the responding patients had tumors that were microsatellite stable, which is a subgroup of patients who have historically experienced a less than ten percent response rate to KEYTRUDA monotherapy.

DKN-01/PACLITAXEL: At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, Leap presented an update on a clinical study evaluating DKN-01 in combination with paclitaxel in patients with advanced esophagogastric cancer. The combination of DKN-01 and paclitaxel generated a 46.7% overall response rate, 19.6 weeks median progression free survival, and 61.1 weeks median overall survival in fifteen evaluable patients as a second line therapy. In the benchmark RAINBOW study, paclitaxel monotherapy in second line gastroesophageal junction or gastric cancer patients generated a 16.1% overall response rate, 2.9 months median progression free survival, and 7.4 months median overall survival. Additionally, in our study in the subgroup of twelve evaluable patients with heavily pre-treated esophageal squamous cell carcinoma, the combination of DKN-01 and paclitaxel produced a 33.3% overall response rate, 13.7 weeks median progression free survival, and 31.0 weeks median overall survival.

DKN-01 in HCC: The first patient has been enrolled in Leap’s investigator-initiated study of DKN-01 as a monotherapy and in combination with NEXAVAR (sorafenib) in hepatocellular carcinoma patients with Wnt pathway activation.

TRX518/BAVENCIO: In July, Leap announced a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany to evaluate TRX518 in combination with BAVENCIO (avelumab) and cyclophosphamide chemotherapy. Under the terms of the collaboration, Leap will be conducting a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.

· TRX518/KEYTRUDA or OPDIVO or GEMCITABINE: During the third quarter, Leap presented initial data from a clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab). Three patients treated with TRX518 in combination with anti-PD1 antibodies have experienced clinical benefit. An esophageal squamous cell carcinoma patient treated with TRX518 and KEYTRUDA demonstrated a partial response with a 77% reduction in tumor volume, and an ocular melanoma patient experienced stable disease with a 23% reduction in tumor volume. An urothelial carcinoma patient who had progressed while on KEYTRUDA has had a partial response with TRX518 and OPDIVO with a 39% reduction in tumor volume. We have also fully enrolled the TRX518 and gemcitabine expansion cohort. We plan to present additional data from this trial at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in December 2018.

Selected Third Quarter 2018 Financial Results

Net loss was $6.6 million for the third quarter of 2018, compared to $6.8 million for the same period in 2017.

Research and development expenses were $6.5 million for the third quarter 2018, compared to $6.8 million for the same period in 2017. The decrease of $0.3 million was primarily due to a decrease of $1.3 million in manufacturing costs related to clinical trial material. This decrease was partially offset by an increase of $0.7 million in clinical trial costs, an increase of $0.2 million in payroll and other related costs and an increase of $0.1 million in stock based compensation expense.

General and administrative expenses were $2.1 million for the third quarter 2018, compared to $1.8 million for the same period in 2017. The increase of $0.3 million in general and administrative expenses was primarily due to a $0.2 million increase in stock based compensation expense and an increase of $0.1 million in legal, audit and consulting fees associated with corporate and business development activities.

Cash, cash equivalents and marketable securities totaled $23.2 million at September 30, 2018. Research and development incentive receivables totaled $2.1 million. In October 2018, we received $0.8 million of research and development tax incentive payments from the Commonwealth of Australia. We anticipate that our current cash resources will extend until late in the third quarter of 2019.

On November 9, 2018 Leap Therapeutics, Inc. (NASDAQ: LPTX) reported its clinical data from its ongoing Phase I/II study of DKN-01 in combination with paclitaxel in patients with advanced esophagogastric cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting (SITC 2018) (Press release, Leap Therapeutics, NOV 9, 2018, View Source [SID1234531215]).

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The esophagogastric cancer clinical trial (P102) is a multipart study of DKN-01 as a monotherapy and in combination with paclitaxel or pembrolizumab. The arms evaluating DKN-01 plus paclitaxel enrolled fifty-nine patients who had received one to seven prior lines of therapy and were designed to assess the safety, pharmacokinetics and efficacy of the combination.

The combination of DKN-01 and paclitaxel generated a 46.7% overall response rate, 19.6 weeks median progression free survival, and 61.1 weeks median overall survival in fifteen evaluable patients as a second line therapy. In the benchmark RAINBOW study, paclitaxel, as a monotherapy in second line gastroesophageal junction or gastric cancer patients, generated a 16.1% overall response rate, 2.9 months of median progression free survival, and 7.4 months median overall survival.

In addition, in the subgroup of twelve evaluable patients with heavily pre-treated esophageal squamous cell carcinoma, the combination of DKN-01 and paclitaxel produced a 33.3% overall response rate, 13.7 weeks median progression free survival, and 31.0 weeks median overall survival.

"The combination of DKN-01 and paclitaxel has generated a promising signal in second-line esophagogastric cancer patients, with clinically meaningful response rate, progression-free survival and overall survival data. In addition, there were encouraging outcomes in patients with esophageal squamous cell carcinoma, who have a significant unmet medical need and no approved therapies," commented John H. Strickler, MD, Assistant Professor of Medicine, Duke University Cancer Institute. "As GI oncologists, we are looking to improve upon the standard single agent therapies, and the combination of DKN-01 and paclitaxel merits further exploration in randomized clinical trials."

Preclinical data also presented at SITC (Free SITC Whitepaper) 2018 described the mechanism of action of DKN-01 and immune mediated anti-tumor activity in nonclinical models. A murine version of DKN-01 (mDKN-01) demonstrated efficacy in a melanoma tumor model. However, mDKN-01 was unable to impede tumor growth in immunodeficient mice, indicating that a functioning immune system is required for antibody activity. Specifically, the activity of DKN-01 was shown to require NK cells but not T or B cells, representing activation of the innate immune system. In preclinical models, the innate immune system activity of DKN-01 complemented the activity of paclitaxel and anti-PD-1 antibodies.

"To improve outcomes for patients with esophagogastric cancer, we need to develop drugs with new mechanisms of actions. The effect of DKN-01 on the innate immune system provides a strong rationale for enhanced activity in combination with chemotherapy and checkpoint inhibitors," commented Victoria M. Villaflor, MD, Associate Professor of Medicine, Northwestern University. "The DKN-01 clinical data with paclitaxel and as previously presented with Keytruda reflects the clinical translation of these complementary mechanisms and should be studied further as an important new approach for treating esophagogastric cancer patients."

On November 7, 2018 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported updated clinical results for the CYAD-01 program in solid tumors as well as translational research data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting (Press release, Celyad, NOV 9, 2018, View Source [SID1234531096]).

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THINK Phase 1 Trial Update

Results from the dose-escalation trial were reported at SITC (Free SITC Whitepaper) (abstract P255). Overall 14 patients with relapsed/refractory disease (11 mCRC, two ovarian and one pancreatic) were enrolled in the trial, evaluating CYAD-01 without preconditioning chemotherapy at three different dose levels (300 million, 1 billion and 3 billion cells per injection) of one cycle of three administrations with two-week intervals. Patients treated at the highest dose level presenting signs of clinical activity (stable disease or greater) were eligible to receive a second cycle of treatment.
Overall four patients experienced confirmed disease stabilization (three mCRC patients and one patient with ovarian cancer) according to RECIST 1.1 criteria.
As a monotherapy treatment, CYAD-01 was well tolerated. Nine grade 3/4 treatment-related adverse events (AEs) were reported in five different patients including a grade 4 cytokine release syndrome (CRS) in dose level 3 considered as a dose-limiting toxicity (DLT). Five additional patients recruited at the same dose showed no further evidence of severe toxicity.
The peak level of peripheral CYAD-01 cells detected seem to correlate with the dose level and clinical response.
SHRINK Phase 1 Trial Update

The open-label, dose-escalation Phase 1 trial is assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX chemotherapy in patients with liver metastases from colorectal cancer (CRC). Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks 48 hours after the end of chemotherapy at cycles two, three and four. Based upon initial assessment of clinical activity, patients could be eligible to receive three additional administrations of CYAD-01 at the same dose level.
To date, enrollment of dose level one (100 million cells per injection) has been completed with three metastatic treatment-naïve patients. All patients have undergone resection without delays in surgery.
Initial activity results assessed by pathological response criteria showed all three patients achieved an objective clinical response, including one patient with a pCR and two patients with pPR.
Concurrent treatment of CYAD-01 with FOLFOX chemotherapy appears to be well tolerated, with no occurrence of serious AEs (SAEs) nor increase of treatment-related AEs rate.
In addition, the expansion of peripheral CYAD-01 cells with a concurrent administration of FOLFOX chemotherapy is similar to the one observed with the standalone CYAD-01.
Full data from the SHRINK Phase 1 trial are expected in mid-2019.
THINK CyFlu Phase 1 Cohort Update

In February 2018, the THINK trial was amended to include a cohort known as THINK CyFlu (previously referred to as DEPLETHINK-CRC). The cohort evaluates a single injection of CYAD-01 following treatment with the standard preconditioning regimen of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²), or CyFlu. CyFlu is administered daily at days -5, -4 and -3 prior to treatment with CYAD-01.
To date, two patients have been enrolled into the cohort and completed the treatment schedule at the dose of 300 million cells per injection. Treatment with CYAD-01 following the standard preconditioning regimen of CyFlu was well tolerated with no occurrence of SAEs nor an increase of treatment-related AEs rate. As of November 9, the two enrolled patients were not yet evaluable for clinical response.
Preliminary translational data suggest an improvement in the cell expansion of CYAD-01 induced by the CyFlu preconditioning.
Full data from the THINK CyFlu Phase 1 cohort are expected in mid-2019.

Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented, "Solid tumors remain the greatest current challenge for any T cell therapy. One of the major hurdles is the lack of suitable targets, and in our perspective, NKG2D ligands that are targeted by CYAD-01 represent an attractive family of targets on solid tumors that may be exploited by our clinical candidates. I am encouraged that to date CYAD-01 is well tolerated as a monotherapy for the treatment of mCRC, while preliminary observations of clinical activity in the form of disease stabilization imply that there is potential for the approach. Furthermore, the initial findings of clinical activity reported from the initial dose level of CYAD-01 when administered concurrently with standard-of-care chemotherapy in the SHRINK trial are encouraging and provide support for this view."

Celyad also highlighted several updates to the broader solid tumor development program and non-gene edited, allogeneic platforms.

LINK Phase 1 Trial Update

Following a strategic review of the CYAD-01 program in CRC, the Company has decided to stop enrollment of the LINK trial. The dose-escalation study had planned to assess the safety and clinical activity of multiple hepatic transarterial administrations of CYAD-01 in patients with unresectable liver metastases from CRC. To date, one patient in dose level one has been enrolled in the study.
alloSHRINK Phase 1 Trial Update

In July 2018, the U.S. Food and Drug Administration (FDA) permitted the Investigational New Drug (IND) application for CYAD-101, the world’s first non-gene edited, allogeneic CAR-T clinical candidate, to go into effect. As previously announced, CYAD-101 will initially be evaluated in the alloSHRINK trial.
alloSHRINK is an open-label, dose-escalation trial that will assess the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with unresectable mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks 48 hours after the initiation of chemotherapy cycles one, two and three.
Enrollment in the trial is expected to begin by year-end 2018 with topline data anticipated during the second half of 2019.
Next-Generation, Allogeneic shRNA Platform

In October 2018, Celyad announced it had entered into an exclusive agreement with Horizon Discovery Group for the use of its shRNA technology to generate a novel, next-generation, non-gene-edited allogeneic platform. Initial results from preclinical studies demonstrating the versatility of the shRNA technology in the allogeneic setting will also be presented at SITC (Free SITC Whitepaper) (abstract P220). Follow up data for the platform are expected in the first quarter of 2019.
"We are excited about the progress we have made thus far with our solid tumor program for lead candidate CYAD-01," said David Gilham, Ph.D., VP of Research and Development at Celyad. "We continue to investigate complementary regimens for CYAD-01 for the treatment of metastatic colorectal cancer that we believe may help to drive additional clinical activity in this devastating disease where a true unmet medical need exists. Additionally, CYAD-101 offers a first-in-class investigational allogeneic CAR-T for the treatment of mCRC and leverages our overall clinical experience within the indication while strategically positioning the Company to be a leading player in both the autologous and allogeneic CAR-T cell therapy space."

SITC Analyst/Investor Event

Celyad will host an Analyst/Investor event on Saturday, November 10, 2018, beginning at 12:30 p.m. ET to review data presented at SITC (Free SITC Whitepaper). The company presentation for the event will be available under Events & Webcasts in the Investors section of the Company’s website.

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational, autologous CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the company’s CYAD-01 CAR-T construct and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). TCR signalling is responsible for Graft versus Host Disease (GvHD). The expression of TIM reduces signalling of the TCR complex and could therefore reduce or eliminate GvHD in patients treated with CYAD-101

On November 9, 2018 Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported its clinical research data on cohort E from a Phase Ib clinical trial at the International Association for the Study of Lung Cancer (IASLC) Asia Conference on Lung Cancer 2018 (#ACLC18) (Press release, Innovent Biologics, NOV 9, 2018, View Source [SID1234531216]). In this cohort of the Phase Ib clinical trial (NCT02937116), patients with first-line squamous non-small cell lung cancer (sNSCLC) were treated with sintilimab, a fully human anti-programmed cell death 1 (PD-1) monoclonal antibody, in combination with gemcitabine and cisplatin.

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The combination demonstrated an objective response rate (ORR) of 64.7% and disease control rate (DCR) of 100.0%, based on data from 17 patients with at least one radiological assessment among a total of 20 patients in this cohort. As of the data analysis cutoff on September 1, 2018, after median follow up of 6.6 months, the data of median duration of response (DOR) and median progression free survival (PFS) were not yet mature, the preliminary results of which were 6.0 months and 6.8 months, respectively. Twelve-month overall survival (OS) was 87.0%. The study shows evidence of anti-tumor efficacy and an acceptable safety profile.

Based on the efficacy and safety profile from this early phase clinical trial, we have initiated ORIENT-12, a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with gemcitabine and platinum-based chemotherapy as first-line treatment for advanced or recurrent sNSCLC in China. Patient recruitment for this study is currently under way and Innovent plans to enroll 348 patients. The first patient dosing has been accomplished recently.

"Immune checkpoint inhibitor has brought hope to patients suffering from squamous non-small cell lung cancer, who are unfit for either target therapy due to its lack of driving gene mutation, or anti-angiogenic therapy in first line setting," said Professor Kejing Ying from Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. She expressed her great expectation for the result from phase III clinical trial and the approval of sintilimab as first-line treatment for NSCLC.

"Lung cancer has the highest morbidity and mortality among malignant tumors in China. Despite breakthrough in recent years, treatment for squamous lung cancer is still limited, and the effect is unsatisfying," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "At present, Innovent has launched phase III clinical study of squamous lung cancer. We hope these clinical trials will benefit squamous lung cancer patients as quickly as possible, bringing patients and their families hope for extended vitality."

About advanced or metastatic squamous non-small cell lung cancer (sNSCLC)

Lung cancer has the highest incidence and mortality among all malignancies in China. NSCLC accounts for about 80% to 85% of all lung cancer cases, and about 70% of NSCLC patients have locally advanced or metastatic disease at first diagnosis. In addition, many patients with early-stage NSCLC after undergoing potentially curative surgery eventually die from disease progression after disease recurrence or distant metastasis. Squamous NSCLC (sNSCLC) accounts for about 30% of all NSCLC patients in China. Due to its unique epidemiological, histological and molecular biological character, sNSCLC still lacks effective treatment modality, with platinum-based chemotherapy as the first-line treatment. However, platinum-based chemotherapy only obtains an objective response rate (ORR) of 30%, progression free survival (PFS) of 5.5 months and overall survival (OS) of 10.8 months, which is far from satisfying. The unmet medical needs in this patient population are high.

About ORIENT-12

ORIENT-12 is a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with gemcitabine and platinum-based chemotherapy as first-line treatment for advanced or recurrent sNSCLC in China. Patient recruitment for this study is currently under way and Innovent plans to enroll 348 patients. The first patient dosing has been accomplished recently.

About Sintilimab

Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, successor to CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.