`
`Patient Information
`
`Wagner et al, “Clinical Activity of
`mTOR Inhibition With Sirolimus in
`Malignant Perivascular Epithelioid Cell
`Tumors: Targeting the Pathogenic
`Activation of mTORC1 in Tumors,” J.
`Clin. Oncol. 28:835-840 (2010) at p.
`836.
`Piovesan et al., “Response to sirolimus
`in combination to tyrosine kinase
`inhibitors (TKI) in three cases of
`PDGFRA-D842V metastatic
`gastrointestinal stromal tumor (GIST),”
`J. Clin. Oncol. 27:10565 (2009) at
`Abstract.
`Gonzalez-Angulo et al., “Weekly nab
`Rapamycin in Patients with Advanced
`Nonhematologic Malignancies: Final
`Results of a Phase I Trial,” Clin. Cancer
`Res. 19(19):5474-5484 (2013) at pp.
`5475, 5477, 5480.
`
`Drug: Rapamycin
`Total patients: 3
`Tumor type: Perivascular epithelioid
`cell tumor
`Single-arm
`Uncontrolled
`
`Drug: Rapamycin plus TKI
`Total patients: 3
`Tumor type: Gastrointestinal stromal
`tumors
`Single-arm
`Uncontrolled
`
`Drug: Nab-rapamycin
`Total patients: 27
`Treated patients: 26
`Patients evaluable: 19
`Tumor types (patient number):
` Bladder (1)
` Breast (1)
` Colorectal (3)
` Esophagus (2)
` Head and neck (3)
` Kidney (3)
` Lung/thoracic (2)
` Prostate (1)
` Stomach (1)
` Uterus (1)
` Other (8)
`o Neuroendocrine (1)
`Single-arm
`Uncontrolled
`Phase I
`
`NOVARTIS EXHIBIT 2182
`Par v Novartis, IPR 2016-00084
`Page 1 of 3
`
`
`
`Jimeno et al., “Pharmacodynamic
`Guided Modified Continuous
`Reassessment Method-Based, Dose
`Finding Study of Rapamycin in Adult
`Patients With Solid Tumors,” J. Clin.
`Oncol. 26:4172-4179 (2008) at pp.
`4173, 4175.
`
`Acevedo-Gadea et al., “Sirolimus and
`trastuzumab combination therapy for
`HER2-positive metastatic breast cancer
`after progression on prior trastuzumub
`therapy,” Breast Cancer Res. Treat.
`150:157-167 (2015) at pp. 157-159.
`
`Choo et al., “A Phase 1 dose-finding
`and pharmacodynamic study of
`rapamycin in combination with
`bevacizumab in patients with
`unresectable hepatocellular carcinoma,”
`Eur. J. Cancer 49:999-1008 (2013) at
`pp. 999-1000.
`
`Cloughesy et al., “Antitumor Activity of
`Rapamycin in a Phase I Trial for
`Patients with Recurrent PTEN-Deficient
`Glioblastoma,” PLoS Medicine
`5(1):139-151 (2008) at p. 140.
`
`Drug: Rapamycin
`Total patients: 21
`Patients evaluable: 21
`Tumor types (patient number):
` Sarcoma (4)
` Pancreas (adenocarcinoma) (4)
` Colorectal (3)
` Hepatocellular (3)
` Neuroendocrine (3)
` Other (4)
`Single-arm
`Uncontrolled
`Phase I
`Drug: Sirolimus plus trastuzumab
`Total patients: 11
`Patients evaluable for response: 9
`Tumor type: Metastatic HER2-positive
`breast cancer following disease
`progression on prior trastuzumab
`therapy
`Single-arm
`Uncontrolled
`Phase II
`Drug: Rapamycin plus bevacizumab
`Total patients: 24
`Tumor type: Advanced hepatocellular
`carcinoma
`Open-label
`Single-arm
`Uncontrolled
`Phase I
`Drug: Rapamycin
`Total patients: 15
`Tumor type: glioblastoma
`Single-arm
`Uncontrolled
`Phase I
`
`NOVARTIS EXHIBIT 2182
`Par v Novartis, IPR 2016-00084
`Page 2 of 3
`
`
`
`Marrari et al., “Effect of adding
`sirolimus (s) to imatinib (im) on tumor
`response following secondary resistance
`to im in advanced chordoma,” J. Clin.
`Oncol. 26:10541 (2008) at Abstract.
`Stacchiotti et al., “Sirolimus in
`advanced hemangioendothelioma,” J
`Clin. Oncol. 31:10565 (2013) at
`Abstract.
`
`Stallone et al., “Sirolimus for Kaposi’s
`Sarcoma in Renal-Transplant
`Recipients,” NEJM 352:1317-1323
`(2005) at p. 1318.
`
`Drug: Rapamycin plus imatinib
`Total patients: 7
`Tumor type: Advanced chordoma
`Single-arm
`Uncontrolled
`Drug: Rapamycin
`Total patients: 12
`Patients evaluable for response: 10
`Tumor type: Haemangioendothelioma
`Single-arm
`Uncontrolled
`Drug: Rapamycin
`Total patients: 15
`Tumor type: Kaposi’s sarcoma
`Single-arm
`Uncontrolled
`
`NOVARTIS EXHIBIT 2182
`Par v Novartis, IPR 2016-00084
`Page 3 of 3
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