NRG Oncology Research Strategy Committee Update

Mitchell Machtay, M.D.Deputy Group Chair for Research Strategy

July 12, 2014

NRG StructureRSC and CPAC Report to Group Chairs

NRG Research StrategyCommittee (RSC)

• NRG Internal Peer review of Protocol concepts submitted by NRG committees – ~50 members.

• Meets face-to-face at semi-annual meetings.– Periodic teleconferences between meetings.

• Voting and scoring performed by the RSC members via survey-monkey post-meeting.

• Protocol concepts with a ‘positive’ vote are sent to NRG CPAC for prioritization

Voting/Prioritizing Scientific Merit Score

Score Adjectival Descriptor

1 Outstanding (top 20%, worth finding resources)

2 Excellent (worth conducting if resources available)

3 Good (conduct only if excess resources available)

4 Poor (near fatal flaw, conduct only if desperate)

5 Do not consider further (even if desperate)

Feasibility ScoreScore Adjectival Descriptor1 Fully feasible (answers study questions, patients available)

2 Partially feasible (only one of above two criteria present)

3 Not feasible (neither of two criteria present)

RSC Concepts ApprovedBy NRG Thus Far

• Legacy protocols already well under development by NSABP, RTOG, GOG.

• Series of ‘Nivo’ protocol concepts in response to high priority NCI mass solicitation.– Brain, H&N, Lung, Cervix, Ovary

• Nine protocol concepts formally reviewed and presented at February 2014 NRG meeting:– 2 brain; 4 GYN; 2 Lung; 1 Sarcoma

• Brain/CNS: 2• Breast: 2• Gastrointestinal: 1• Genitourinary: 2• Gyn (incl. Dev. Ther.): 3• Head & Neck: 1• Lung/Thoracic: 1• CPC: 1

OEWG Developing Studies(Concepts NCI Approved)

Developing Concepts(Concepts NRG RSC Approved

But not yet NCI approved)

• Brain/CNS: 3• Breast: 1• Gastrointestinal: 0• Genitourinary: 0• Gyn (incl. Dev. Ther.): 9• Head & Neck: 0• Lung/Thoracic: 1• CPC: 1

OEWG Developing Studies(i.e. NCI approved concepts)

• Breast: N=2– BR-001: Multifocal SBRT for oligometastatic disease (Ph. I)– BR-002: Unifocal SBRT for oligometastatic disease (Ph. II/III)

• Gynecologic: N=3– GY-001: XL-184 for recurrent ovarian CA (Ph. II)– GY-00x: Nivolumab for recurrent cervix CA (Ph. II)– GY-00x: Nivolumab/Ipilimumab for adv. ovarian CA (Ph. II)

• Cancer Control/Prevention: N=1– CC-001: Memantine/hippocampal sparing brain RT for

metastases (Ph. III)

OEWG Developing Studies(i.e. NCI approved concepts)

• Brain/CNS: N=2– BN-001: High dose IMRT/protons for GBM (Ph. III)– BN-002: RT/Temodar/Nivolumab for GBM (Ph. I)

• Head and Neck: N=2– HN-001: EBV-based chemo-RT for Nasoph CA (Ph II/III).– HN-002: RT/chemo dose for HPV+ Oroph. (Ph II)

• Gastrointestinal: N=1– GI-001: Chemo +/- RT for CholangioCA (Ph. III)

• Lung: N=1– LU-001: Chemo-RT +/- Metformin for Lung CA (Ph. II)

• Genitourinary: N=1– GU-001: Postop IMRT for Loc. Adv. bladder CA (Ph. II/III)

NRG Developing Concepts(i.e. RSC approved but not NCI approved)

• Brain: N=3– RT + Veliparib (ABT-888) for GBM (Ph. IIR)– RT/Temodar + Valcyte for GBM (Ph. IIR)– Postop RT for Atypical Meningioma (Ph. IIR)

• Breast: N=1– Advanced Imaging/biopsies after Neoadjuvant Tx. (Ph. II)

• Lung: N=2– Local RT/SBRT for oligometastatic Stage IV NSCLC (Ph. IIR)– Pazopanib after SBRT for oligometastatic sarcoma (Ph. IIR)

• Cancer Control/Prevention: N=1– Hippocampal sparing prophylactic cranial irradiation for small

cell lung CA.

NRG Developing Concepts(i.e. RSC approved but not NCI approved)

• GYN (incl. Dev. Ther.): N= 9– Paclitaxel +/- Nintedanib (BIBF1120) for Adv. Endometrium.– Chemo-RT +/- Triapine for Loc. Adv. Cervix CA.– Chemo vs. Trametinib for L.G. Serous Ovary CA– Trametinib + GSK214179 (akt-i) for L.G. Serous Ovary CA– IMGN 853 + carbo vs. chemo for Ovarian CA– Carbo/Paclitaxel +/- OMF-54F28 for Uterine sarcoma– Cediranib/Olaparib vs. chemo for rec. Ovary (Pt sensitive).– Cediranib vs. Olaparib vs. both for rec. Ovary (Pt resistant)– Lymphadenectomy vs. no Lymphadenecotomy Endometrial CA

Summary• NRG ‘Pipeline’ includes:

– 13 studies ‘approved’ by NCI, on OEWG timeline.– 15 studies ‘approved’ by NRG-RSC, being submitted

or resubmitted to NCI.

• Heavily weighted toward GYN cancer (including Dev. Therapeutics).

• Heavily weighted toward early phase trials.• Consistent with NCI goals for the new NCTN to

have fewer trials, less accrual than previously.

The King (of Protocols)is Back!