Trial Outcomes & Findings for Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer (NCT NCT02272413)

Last Updated: 2020-01-13

Results Overview

ORR was defined as the percentage of patients who achieved at least one visit response of complete response (CR) or partial response (PR) after the start of treatment. The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Tumor assessments were performed prior to trial drug administration, until 18 weeks.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

671 participants

Primary outcome timeframe

Tumor assessment scans were performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12) and at Week 18 ±14 days. Best ORR evaluated until confirmed disease progression, unacceptable toxicity, death or up to 18 weeks, whichever happened earlier.

Results posted on

2020-01-13

Participant Flow

Phase III, randomized, double-blind, multicenter, active comparator, parallel 2-arm trial in patients with advanced non-squamous non-small cell lung cancer (nsNSCLC). From 21December2017, Sponsor recommended, patients to be switched from BI 695502 to reference product Avastin® (commercially available) as soon as it was available at clinical site.

All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were violated.

Participant milestones

Participant milestones
Measure	BI 695502 Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
Randomized Through Treatment Start STARTED	338	333
Randomized Through Treatment Start Treated	335	328
Randomized Through Treatment Start COMPLETED	335	328
Randomized Through Treatment Start NOT COMPLETED	3	5
Pre-switch Period STARTED	335	328
Pre-switch Period COMPLETED	42	46
Pre-switch Period NOT COMPLETED	293	282
Post-switch Period STARTED	42	46
Post-switch Period COMPLETED	0	0
Post-switch Period NOT COMPLETED	42	46

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 695502 Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
Randomized Through Treatment Start Not treated	3	5
Pre-switch Period Adverse Event	38	37
Pre-switch Period Death	26	26
Pre-switch Period Withdrawal by Subject	27	15
Pre-switch Period Physician Decision	6	18
Pre-switch Period Progressive disease	185	173
Pre-switch Period Lost to Follow-up	0	2
Pre-switch Period Protocol Violation	1	0
Pre-switch Period Other than listed	10	11
Post-switch Period Adverse Event	4	4
Post-switch Period Death	3	2
Post-switch Period Withdrawal by Subject	1	2
Post-switch Period Physician Decision	1	1
Post-switch Period Progressive disease	21	21
Post-switch Period Study terminated by sponsor	8	11
Post-switch Period Other than listed	4	5

Baseline Characteristics

Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 695502 n=335 Participants Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US n=328 Participants Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Total n=663 Participants Total of all reporting groups
Age, Continuous	61.2 Years STANDARD_DEVIATION 9.89 • n=5 Participants	61.3 Years STANDARD_DEVIATION 9.22 • n=7 Participants	61.2 Years STANDARD_DEVIATION 9.55 • n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	125 Participants n=7 Participants	246 Participants n=5 Participants
Sex: Female, Male Male	214 Participants n=5 Participants	203 Participants n=7 Participants	417 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants	34 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	284 Participants n=5 Participants	285 Participants n=7 Participants	569 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	64 Participants n=5 Participants	71 Participants n=7 Participants	135 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	258 Participants n=5 Participants	248 Participants n=7 Participants	506 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Tumor assessment scans were performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12) and at Week 18 ±14 days. Best ORR evaluated until confirmed disease progression, unacceptable toxicity, death or up to 18 weeks, whichever happened earlier.

Population: The FAS contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment. Best ORR (CR+PR) is reported for observed values.

Outcome measures

Outcome measures
Measure	BI 695502 n=335 Participants Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US n=328 Participants Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment	54.0 Percentage of patients (%)	63.1 Percentage of patients (%)

SECONDARY outcome

Timeframe: From first dose of trial drug until 16 weeks after the last dose of trial medication, up to 218 days.

Population: The Treated Set contained all patients who signed informed consent and who received at least one dose of trial drug.

The following selected adverse events (AEs) were evaluated for comparability assessment of BI 695502 and US-licensed Avastin®: * Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions), * Thromboembolic events (arterial or venous), * Febrile neutropenia, * Gastrointestinal perforations, * Hypertension, * Proteinuria, * Pulmonary hemorrhage, * Other hemorrhages (not including pulmonary hemorrhages), * Wound-healing complications/abscess/fistulas. The analysis of AEs was based on the concept of TEAEs. For non-switched patients, all AEs that started or worsened in severity on or after the first dose of trial drug and prior to the date of last administration of trial medication + 16 weeks inclusive were defined as TEAEs.

Outcome measures

Outcome measures
Measure	BI 695502 n=335 Participants Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US n=328 Participants Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Febrile neutropenia	3.90 Percentage of patients (%) Interval 2.08 to 6.54	3.40 Percentage of patients (%) Interval 1.69 to 5.92
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Gastrointestinal perforations	2.10 Percentage of patients (%) Interval 0.84 to 4.26	0.60 Percentage of patients (%) Interval 0.07 to 2.19
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Proteinuria	15.80 Percentage of patients (%) Interval 12.08 to 20.18	14.60 Percentage of patients (%) Interval 10.99 to 18.93
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® AtLeast 1 AE selected for Comparability Assessment	52.50 Percentage of patients (%) Interval 47.04 to 57.99	45.10 Percentage of patients (%) Interval 39.65 to 50.68
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Infusion reactions	16.70 Percentage of patients (%) Interval 12.88 to 21.15	13.10 Percentage of patients (%) Interval 9.65 to 17.25
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Thromboembolic events	6.60 Percentage of patients (%) Interval 4.16 to 9.77	5.50 Percentage of patients (%) Interval 3.28 to 8.53
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Hypertension	15.50 Percentage of patients (%) Interval 11.82 to 19.85	16.20 Percentage of patients (%) Interval 12.34 to 20.6
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Pulmonary haemorrhage	1.20 Percentage of patients (%) Interval 0.33 to 3.03	0.90 Percentage of patients (%) Interval 0.19 to 2.65
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Other hemorrhages	20.00 Percentage of patients (%) Interval 15.85 to 24.69	16.20 Percentage of patients (%) Interval 12.34 to 20.6
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® Wound-healing complications/abscess/fistulas	2.70 Percentage of patients (%) Interval 1.24 to 5.04	2.10 Percentage of patients (%) Interval 0.86 to 4.35

SECONDARY outcome

Timeframe: Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression. Analysis performed for pre-switch period only; maximum duration of up to 35 cycles (105 weeks).

Population: The Full Analysis Set (FAS) contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment.

PFS was defined as the time from randomization until disease progression as determined by Investigator assessment or death from any cause, whichever occurred first during the pre-switch period. Disease progression was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters. Tumor assessments were performed prior to trial drug administration. PFS was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	BI 695502 n=335 Participants Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US n=328 Participants Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
Progression-Free Survival (PFS) Time as Determined by Investigator Assessment	8.34 Months Interval 7.49 to 8.77	9.00 Months Interval 8.34 to 10.38

SECONDARY outcome

Timeframe: From baseline until death due to any cause, ie., up to 35 cycles (105 weeks).

Population: The FAS contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment.

OS was defined as the time randomization until death from any cause during the pre-switch period. OS was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	BI 695502 n=335 Participants Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US n=328 Participants Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
Overall Survival (OS) Time	15.57 Months Interval 14.16 to 17.25	19.48 Months Interval 15.87 to 20.73

SECONDARY outcome

Timeframe: Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression., ie up to 35 cycles (105 weeks).

Population: The FAS contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment. Only patients with an objective response were included in the analysis.

DOR was the time from first documented CR or PR until time of progression as determined by Investigator assessment during the pre-switch period. Tumor assessments were performed prior to trial drug administration. DOR was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	BI 695502 n=175 Participants Patients received BI 695502 solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 body surface area (BSA), followed by carboplatin target area under the curve (AUC) 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with BI 695502 monotherapy could be started per the original randomization. Patients then received BI 695502 as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.	Avastin® US n=187 Participants Patients received US-licensed Avastin® solution for i.v. infusion, 15 mg/kg bw, every 3 weeks for up to 6 cycles. During the induction cycles, patients also received standard combination chemotherapy consisting of paclitaxel 200 mg/m\^2 BSA, followed by carboplatin target AUC 6 mg/mL\*min, with adequate pre- and concomitant medication. After Cycle 4 to 6, for responding or stabilized patients, maintenance treatment with US-licensed Avastin® monotherapy could be started per the original randomization. Patients then received US-licensed Avastin® as a single agent until disease progression, death, withdrawal of consent, unacceptable toxicity, or until the Switch Visit (when each patient was switched to receive commercially available Avastin®), whichever occurred earlier.
Duration of Response (DOR) as Determined by Investigator Assessment	7.66 Months Interval 7.03 to 9.03	8.94 Months Interval 7.26 to 10.28

Adverse Events

BI 695502 (Pre-switch)

Serious events: 108 serious events

Other events: 293 other events

Deaths: 193 deaths

US-licensed Avastin® (Pre-switch)

Serious events: 89 serious events

Other events: 288 other events

Deaths: 184 deaths

BI 695502 (Post-switch)

Serious events: 5 serious events

Other events: 20 other events

Deaths: 3 deaths

US-licensed Avastin® (Post-switch)

Serious events: 2 serious events

Other events: 22 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER