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Part 1: NIR178 continuously in combination with PDR001 400mg every 4 weeks. The part 1 enrolled 9 different tumor types.

Part 2: Three different dosing schedules of NIR178 twice daily (BID) including continuous and two intermittent in combination with PDR001

Further evaluation of optimal intermittent or continuous schedule of NIR178 in combination with PDR001 (if selected based on results of Part 2). A film-coated tablet of NIR178 was assessed.

Different dosing schedules of NIR178 were explored.

NIR178, a new, non-xanthine based compound, is a potent oral adenosine A2a receptor against antagonist being developed by Novartis.

NIR178 was administered orally twice daily (BID) as a capsule (Part 1, Part 2 and Japanese safety run-in) and as a film-coated table (Part 3). There were up to 3 dose levels assessed: 80, 160 and 240 mg. Three alternative dosing schedules were evaluated: continuous (Part 1, Part 2, Part 3, Japanese safety run-in), 2 weeks on/2 weeks off (Part 2) and 1 week on/1 week off (Part 2).

Each cycle consisted of 28 days.

NIR178

PDR001 is a human monoclonal antibody (MAb) administered on Day 1 of each cycle. PDR001 400 mg was administered via intravenous (i.v.) infusion over 30 minutes every 4 weeks (Q4W).

PDR001

The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

This is an open-label multi-part, phase II study evaluating the combination of NIR178 and PDR001 in patients with advanced solid tumors and diffuse large B cell lymphoma (DLBCL).

The study has three parts:

* Part 1: Multi-arm Bayesian adaptive signal finding design in solid tumors and diffuse large B cell lymphoma (DLBCL) with continuous dosing of NIR178 in combination with PDR001.
* Part 2: Exploration of continuous and intermittent NIR178 schedules in combination with PDR001 in patients with advanced non-small cell lung cancer (NSCLC).
* Part 3: Further evaluation of optimal intermittent or continuous schedule of NIR178 in combination with PDR001 (if selected based on results of Part 2). As of protocol amendment 6, Part 3 explored the safety and pharmacokinetics of the film-coated tablet (FCT) formulation of NIR178 continuous dosing in combination with PDR001 in tiple negative breast cancer (TNBC) patients.

In addition, a separate safety run-in part was conducted in Japan in order to adequately characterize the safety and pharmacokinetic profiles of NIR178 as a single-agent and in combination with PDR001.

Patients enrolled in this study received NIR178 either twice daily (BID) continuously or based on the assigned intermittent schedule within 60 minutes prior to PDR001 infusion. PDR001 400 mg was administered via IV infusion over 30 minutes once every 4 weeks. Each treatment cycle was 28 days. Patients enrolled in the Japanese safety run-in part received NIR178 as single agent for the first cycle (28 days). If the patients completed Cycle 1 without experiencing dose limiting toxicities (DLTs), they initiated combination therapy with PDR001 starting Cycle 2 onwards, and continued at the same dose of NIR178. An additional cohort in the Japanese safety run-in part of the study received NIR178 in combination with PDR001 starting with Cycle 1. If the patients complete Cycle 1 without experiencing DLTs, they continued to receive combination treatment.

Patients received treatment with the combination until disease progression (assessed by investigator per immune-related response criteria (iRECIST) or Cheson 2014), unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment.

Part 1, Part 3 and the Japanese safety run-in part were not randomized. In Part 2, patients were randomized to one of the 3 treatment arms in a ratio of 1:1:1.

A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL).

For Cheson 2014 criteria, CR= Target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi), no extralymphatic sites of disease, absent non-measured lesions, organ enlargement regress to normal, no new lesions, and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative); PR= ≥50% decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes, absent or regressed non-measured lesions, spleen must have regressed by \>50% in length beyond normal, and no new lesions.

ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1.

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).

Prostate-specific antigen (PSA) levels were assessed in serum. Rising PSA is generally a manifestation of progression of prostate cancer.

DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).

DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL).

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.

DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.

DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per Cheson 2014 criteria for DLBCL. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1.

PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST.

PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per Cheson 2014 for DLBCL.

PFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.

OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan (SAP).

OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan.

The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.

Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.

The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.

Number of participants with at least one dose reduction of NIR178 and number of participants with at least one dose interruption of NIR178. Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule.

Number of participants with at least one dose reduction of PDR001 and number of participants with at least one dose interruption of PDR001. Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule. Dose reductions were not permitted for PDR001.

Dose intensity of NIR178 was calculated as cumulative actual dose in milligrams divided by duration of exposure in days.

Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.

PDR001 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows:

* ADA-negative at baseline: ADA-negative sample at baseline
* ADA-positive at baseline: ADA-positive sample at baseline
* ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
* Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
* Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample
* Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
* ADA-inconclusive: patient who does not qualify for any of the above definitions or a patient for which the baseline sample is missing

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with NIR178 as single agent or in combination with PDR001 during the Japan safety run-in part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.

PK parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.

NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

NJI765 is a NIR178 metabolite. Pharmacokinetic (PK) parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.

NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-28day calculation.

Novartis Pharmaceuticals

Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: RCC naïve 160 mg

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: RCC naïve + Pre 240 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: Pancreatic 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: Urothelial 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: H-N naïve + Pre 160 mg

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: H-N Pre 240 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: MSS CRC 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC). Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: TNBC 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: Melanoma naïve + Pre 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: DLBCL 160 mg

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: DLBCL 240 mg

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC). Safety data up to 150 days after last dose of NIR178+PDR001

Part 1: mCRPC 240 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001

Part 2: NSCLC 160 mg Cont

NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001

Part 2: NSCLC 160 mg 2wk-on/2wk-off

NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001

Part 2: NSCLC 160 mg 1wk-on/1wk-off

Part 3: TNBC 160 mg Cont

NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001

JSR: 80 mg Cont

NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001

JSR: 160 mg Cont

NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001

JSR: 240 mg Cont

Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.

Part 1: RCC naïve 160 mg_Survival Period

Part 1: RCC naïve + Pre 240 mg_Survival Period

Part 1: Pancreatic 160 mg_Survival Period

Part 1: Urothelial 160 mg_Survival Period

Part 1: H-N naïve + Pre 160 mg_Survival Period

Part 1: H-N Pre 240 mg_Survival Period

Part 1: MSS CRC 160 mg_Survival Period

Part 1: TNBC 160 mg_Survival Period

Part 1: Melanoma naïve + Pre 160 mg_Survival Period

Part 1: DLBCL 160 mg_Survival Period

Part 1: DLBCL 240 mg_Survival Period

Part 1: mCRPC 240 mg_Survival Period

Part 2: NSCLC 160 mg cont_Survival Period

Part 2: NSCLC 160 mg 2wk-on/2wk-off_Survival Period

Part 2: NSCLC 160 mg 1wk-on/1wk-off_Survival Period

Part 3: TNBC 160 mg cont_Survival Period

JSR: 80 mg cont_Survival Period

JSR: 160 mg cont_Survival Period

JSR: 240 mg cont_Survival Period

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy

Part 1: RCC naïve 240 mg

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy

Part 1: RCC Pre 240 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy

Part 1: H-N naïve 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy

Part 1: H-N Pre 160 mg

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype

Part 1: MSS CRC wt 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant

Part 1: MSS CRC mu 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with unknown RAS status

Part 1: MSS CRC Unk 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had not been previously treated with immuno-oncology therapy

Part 1: Melanoma naïve 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy

Part 1: Melanoma Pre 160 mg

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)

NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)

NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)

NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)

NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)

NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in

NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in

NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma	NCT03207867	NSCLC, Non Smal... RCC, Renal Cell... Pancreatic Canc... Urothelial Canc... Head and Neck C... DLBCL, Diffused... MSS, Microsatel... TNBC, Triple Ne... Melanoma mCRPC, Metastat...	NIR178 PDR001	18 Years -	Novartis
A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma	NCT03207867	NSCLC, Non Smal... RCC, Renal Cell... Pancreatic Canc... Urothelial Canc... Head and Neck C... DLBCL, Diffused... MSS, Microsatel... TNBC, Triple Ne... Melanoma mCRPC, Metastat...	NIR178 PDR001	18 Years -	Novartis

Spots Global Cancer Trial Database for dlbcl, diffused large b cell lymphoma