On November 10, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that data to be presented today at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) demonstrated preliminary evidence that IPI-549 in combination with Opdivo (nivolumab) is clinically active in indications not expected to respond to Opdivo alone (Press release, Infinity Pharmaceuticals, NOV 10, 2018, View Source [SID1234531169]). In particular, evidence of reversal of resistance to Opdivo included a partial response in a patient with metastatic melanoma who progressed on immediate prior Opdivo therapy. IPI-549 plus Opdivo also resulted in a 26% reduction of tumor target lesions in a patient with chemotherapy-resistant triple negative breast cancer (TNBC), a tumor type intrinsically resistant to checkpoint inhibition. The data also included long-term follow up on sustained partial responses in two patients from combination dose escalation: one with microsatellite stable (MSS) gallbladder cancer and one with adrenocortical carcinoma. The observed early clinical activity from the combination expansion, in addition to findings from the monotherapy cohorts, including associated translational data, support on-mechanism proof of concept for IPI-549. The late-breaking abstract describing these findings will be presented today in a poster presentation at the SITC (Free SITC Whitepaper)’s 33rd Annual Meeting taking place in Washington, D.C., November 7 – 11, 2018.

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"There continues to be a significant need for improvement in the treatment of patients with advanced solid tumors who do not respond to checkpoint inhibitors alone. IPI-549’s potential to improve upon the existing CPIs makes it an important first-in-class drug in development," said David Hong, M.D. Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. "The reversal of resistance to checkpoint inhibition is particularly encouraging for the further development of IPI-549, and I look forward to my continued participation in the development of IPI-549."

Infinity is evaluating IPI-549 in MARIO-1, a Phase 1b study in approximately 200 patients with advanced solid tumors. Additionally, Infinity is planning to initiate MARIO-275, a global, randomized Phase 2 study to evaluate the effect of adding IPI-549 to Opdivo in approximately 150 checkpoint-inhibitor naïve advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy.

"The rigorous design of our Phase 1b study sets a high bar for the determination of proof of concept, given that the goals of our study are to see clinical activity both in settings where patients are not expected to respond to Opdivo alone, and in indications where there are high levels of immunosuppressive macrophages," said Dr. Sam Agresta, Chief Medical Officer of Infinity Pharmaceuticals. "We do this with the intention of re-sensitizing patients to Opdivo to overcome the limiting effects of macrophages to checkpoint inhibitor therapy, and we are excited that the data we shared today demonstrate clinical activity in this patient population. We look forward to the maturation of MARIO-1 and the advancement of the IPI-549 clinical development program in the checkpoint-inhibitor naïve setting with MARIO-275."

"Today’s data validate our scientific rationale for the development of IPI-549 as a potentially first-in-class therapeutic alternative for patients lacking better treatment options," said Adelene Perkins, Chief Executive Officer of Infinity Pharmaceuticals. "We will be expanding our melanoma cohort, with patients refractory to immediate prior anti-PD1 therapy, to 40 patients based on promising early signals and have triggered expansion of the TNBC cohort. We will also be initiating our Phase 2 MARIO‑275 trial in urothelial cancer with an emphasis on patients with high myeloid derived suppressor cell levels, given that MDSCs further promote immunosuppression. We look forward to providing an update on these efforts."

Details of Today’s Late-Breaking Presentation

Infinity will present a poster entitled "The first clinical/translational data from the expansion cohorts of a Ph1/1b Study of IPI-549, a tumor macrophage-reprogramming small molecule, in combination with nivolumab in advanced solid tumors" (Poster P716). The data reported today from an October 14, 2018 data cutoff included 82 patients treated with IPI-549 at 40 mg QD and Opdivo at 240mg IV once every two weeks.

Summary of Data

Combination expansion data demonstrated that IPI-549 in combination with Opdivo is well tolerated and is associated with a favorable safety profile. Among 82 patients evaluable for safety, the majority of side effects reported were Grade 1 or Grade 2, with 3 (4%) patients discontinuing the study due to treatment-related toxicities. There were no treatment-related deaths. These 82 patients have been treated in seven distinct cohorts: non-small cell lung cancer (n=8), melanoma (n=15), head and neck cancer (n=12), triple negative breast cancer (n=17), adrenocortical cancer (n=5), mesothelioma (n=11), and a biomarker defined baseline MDSC high cohort (n=14). The majority of the study population is 4th line and resistant to anti-PD1/PDL1 therapy. Among the 44 patients evaluable for activity (approximately one-third of the planned 129 patients in the combination expansion cohorts), 15 patients showed a best response of stable disease or better, including one partial response in an advanced melanoma patient who progressed on immediate prior Opdivo therapy. In addition, a patient with chemotherapy-resistant triple negative breast cancer showed 26% reduction in tumor target lesions at the first assessment. Reductions in elevated baseline levels of MDSCs as well as corresponding increases in the proliferative fraction of previously exhausted memory cytotoxic T-cells were seen in these patients. Another partial response was observed in a patient with advanced mesothelioma. Twenty-five patients remain on study and were not evaluable for activity as of the data cutoff. The data included long-term follow up on additional partial responses in two patients from the combination dose escalation: one with microsatellite stable gallbladder cancer and one with adrenocortical carcinoma and these two partial responses were maintained for over 12 and 17 months, respectively. These patients also demonstrated sustained inhibition of MDSCs during the period in which the partial response was maintained. Enrollment is ongoing.

Infinity Investor/Analyst Reception and Webcast
In conjunction with SITC (Free SITC Whitepaper)’s 33rd Annual Meeting, Infinity will host a reception and webcast for investors and analysts today, November 10, 2018, beginning at 6:30 a.m. ET to discuss the clinical development of IPI-549, including a review of data from the Phase 1b clinical study.

The event will feature David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.

The webcast and accompanying slides can be accessed in the "investors/media" section of the company’s website, www.infi.com. A replay of the event will also be available.

About IPI-549 and the Ongoing MARIO-1 Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the activity of, and overcome resistance to, checkpoint inhibitors.i ii As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with nivolumab (Opdivo) in approximately 200 patients with advanced solid tumors.iii The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer, melanoma and head and neck cancer whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

About the Planned MARIO-275 Phase 2 Study
Infinity is planning to conduct MARIO-275: MAcrophage Reprogramming in Immuno-Oncology, a global, randomized Phase 2 study to evaluate the effect of adding IPI-549 to Opdivo in checkpoint-naïve advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. Approximately 150 patients will be randomized between combination therapy and Opdivo monotherapy. The primary endpoint of the trial will be overall response rate, which will be assessed in the overall population as well as in subsets of patients with different baseline levels of myeloid derived suppressor cells (MDSCs). Opdivo is approved for use by the FDA as a single agent in patients with locally advanced or metastatic urothelial cancer who have progressed or recurred following treatment with platinum-based chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In exploratory analyses of the CheckMate-275 data, high levels of MDSCs were associated with shorter overall survival in patients treated with Opdivo2. In Infinity’s MARIO-1study, MDSCs were reduced in the majority of patients treated with IPI-549 monotherapy.3 IPI-549 in combination with Opdivo has been administered to over 80 patients and demonstrated early evidence of clinical activity with translational studies demonstrating evidence of on-mechanism IPI-549-mediated effects.4

IPI-549 is an investigational compound, and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On November 10, 2018 Dendrogenix a company developing a innovative therapies, reported a first funding round of €3.6M, including €1.2M in capital and €2.4M in grants and recoverable advances from walloon region (Press release, Dendrogenix, NOV 10, 2018, View Source [SID1234539438]).

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On November 10, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that reverse translational and biomarker data derived from its ICONIC (ICOS AgONist Antibody for Immunotherapy in Cancer Patients) trial of JTX-2011 and preclinical data from the ICOS (Inducible T cell CO-Stimulator) program were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, being held November 9-11, 2018 in Washington, D.C (Press release, Jounce Therapeutics, NOV 10, 2018, View Source;p=RssLanding&cat=news&id=2376614 [SID1234531232]).

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"The data presented at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting demonstrate the role of JTX-2011 in the emergence and agonism of ICOS hi CD4 T effector cells and provide further evidence in support of the biological and clinical activity of JTX-2011. The regimens we are advancing, including ongoing combinations with ipilimumab, are grounded in these important scientific findings," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "New insights from our Translational Science Platform continue to inform JTX-2011 clinical development. We believe our science-based approach is necessary to develop new immunotherapies to benefit cancer patients."

Data presented from ICONIC patients demonstrate the agonistic properties of JTX-2011. These data are in addition to the subset analysis data presented at ASCO (Free ASCO Whitepaper) 2018 demonstrating the emergence of ICOS hi CD4 T cells in the bloodstream in all patients with ≥30% target lesion tumor reductions, both in patients treated with JTX-2011 monotherapy and in combination with nivolumab. The ICOS hi CD4 T cells were not observed in patients with primary progressive disease.

"Through additional reverse translational studies presented today, we established two key insights that provide the scientific foundation for the next stage of development of JTX-2011," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "First, the emergence of these ICOS hi CD4 T cells was related to JTX-2011, as it has not been detected in a separate study we conducted of responding and non-responding patients that received PD-1/L1 inhibitor monotherapy treatment; and second, in vitro experimental data showed that JTX-2011 only activates CD4 T cells if they already express high levels of ICOS. Additionally, new preclinical tumor model data presented in a separate poster, strengthens our belief that agents that induce ICOS hi CD4 T cells detectable in the bloodstream, such as anti-CTLA-4, may be attractive combination partners for JTX-2011."

In a poster titled "Emergence of an ICOS hi CD4 T cell subset correlates with tumor reductions in subjects treated with the ICOS agonist antibody JTX-2011," Jounce researchers describe the reverse translational efforts ongoing in the ICONIC trial including:

Follow-up on the initial observation of the emergence of ICOS hi CD4 T cells. Emergence of this cell population, which correlated with clinical benefit in patients treated with both JTX-2011 monotherapy and in combination with nivolumab, was presented at ASCO (Free ASCO Whitepaper) in June 2018. These data build upon the initial observation and provides further characterization of the emerging cell population as T effector and not T regulatory cells and includes evidence that the cells do not emerge in patients responding to PD-1 monotherapy.
Additional in vitro data presented demonstrate that JTX-2011 alone induces a cytokine response from CD4 T cells, only if the T cells have pre-existing ICOS hi characteristics.
CTLA-4 inhibition has been shown to induce a population of ICOS hi cells in the bloodstream, while PD-1 inhibitors do not, and these observations further support the biological rationale for the ongoing clinical development of JTX-2011 in combination with ipilimumab.
In a poster titled "Inducible T cell Co-stimulator (ICOS) is upregulated on lymphocytes following radiation of tumors and ICOS agonism in combination with radiation results in enhanced tumor control," Jounce collaborators at the Earle A. Chile’s Research Institute, Providence Portland Medical Center, highlight the benefit of upregulation of ICOS in circulating and intra-tumoral T cells by radiation and its role in effective combination treatment with an ICOS agonist antibody to mediate tumor reduction. The data presented demonstrate:

The combination of radiation therapy and treatment with an ICOS agonist antibody led to increased anti-tumor response in an immunogenic mouse tumor model.
In a less immunogenic tumor model, response required the combination of ICOS agonist and PD-1 antagonist with radiation, suggesting again that ICOS agonism in combination with modalities that upregulate ICOS, such as with radiation, may represent an attractive regimen for combination immunotherapy of anti-PD-1 resistant tumors.
Both posters are available on the Investors and Media section of the Jounce Therapeutics website under "Presentations & Publications" at www.jouncetx.com.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, a protein on the surface of certain T cells. Preclinical data support that JTX-2011 may have a dual mechanism of action that stimulates anti-tumor T effector cells, and also reduces the immunosuppressive T regulatory cells in the tumor microenvironment. The company is developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies.

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.