Pipeline 2012: Pharma's Front-Runners

Pipeline 2012: Pharma's Front-Runners
Pipeline 2012: Pharma's Front-Runners



Pertuzumab Roche

Indication: Breast cancer (Phase III)

What the clinical trials found: In the Phase II neoadjuvant (prior to surgery) Neosphere trial of 417 women with early-stage, HER2-positive breast cancer, pertuzumab/Herceptin/chemo significantly improved the rate of complete tumor disappearance (or pathological complete response) 45.8% vs. 29% for Herceptin/chemo. In a Phase III trial, the combo regimen met the primary endpoint of progression free survival (PFS), with no new safety signals observed.

inThought Approvability Index and Comment: 63%. Data suggest pertuzumab/Herceptin/chemo provides a more comprehensive blockade of HER signaling pathways than standard of care. Estimated approval: 2012 (Source: Wolters Kluwer inThought).

Revenue forecast: 300 million Swiss francs ($328 million) in 2015, says Sanford Bernstein's Tim Anderson.

What the analysts are saying: This drug could potentially be used in early disease settings, where it was shown to more or less double the response rate. Pertuzumab's future depends on the scope of the increase in PFS vs. Herceptin/chemo, which we don't yet know, and then overall survival, a secondary endpoint. If approved, the HER2-targeted drug would be the first novel targeted agent sanctioned for use in combination with an existing targeted agent and chemo. But the potential increase in cost of therapy is something physicians fear, since Herceptin is already a very pricy therapy. It's also being trialed together with Roche's T-DM1, another HER2-targeted drug in the pipeline. —Petra Maertens, director, oncology syndicated studies, GfK HealthCare

Zaltrap (aflibercept) Regeneron/Sanofi

Indication: Metastatic colorectal cancer (Prereg.), metastatic ­prostate cancer (Phase III)

What the clincial trials found: In the Phase III Velour trial, adding aflibercept to a FOLFIRI regimen improved overall survival 18.3% vs. placebo (p=0.0032) and progression-free survival 24.2% vs. placebo (p=0.00007) in patients with metastatic colorectal cancer (mCRC) previously treated with oxaliplatin.

inThought Approvability Index and Comment: 64% (CRC). Zaltrap looks like a very interesting concept, one which may fill an unmet need for patients who have K-ras-mutation-positive mCRC. Look for a K-ras-mutation companion diagnostic to be developed. Estimated approval: 2012 (Source: Wolters Kluwer inThought).

Revenue forecast: €238 million ($322.7 million) in 2015, says Sanford Bernstein's Tim Anderson.

What the analysts are saying: Zaltrap represents a completely new class of cancer drugs—the recombinant-fusion-protein. Data suggest it has potential in second line for mCRC, where the most commonly used drug, BMS/Lilly's Erbitux, should not be used in some patients (those whose tumors have a certain feature called a K-ras mutation). Zaltrap can be used regardless of patients' K-ras mutation status, opening up the possibility for a further targeted second-line therapy. This could be the first new CRC therapy in five years. Prostate cancer, the follow-up indication, is a more competitive area with four new drugs approved. —Petra Maertens, director, oncology syndicated studies, GfK HealthCare


To see this extended list of other Oncology products in a separate window, click here.

Linifanib (A-741439) Abbott
Liver cancer (Ph. III)

Ganitumab Amgen
Pancreatic cancer (Ph. III)

Trebananib (AMG 386) Amgen
Fallopian tube/ovarian cancer (Ph.

Isavuconazole Astellas
Aspergillosis, candidiasis (Ph. III)

MDV 3100 Astellas
Prostate cancer (Ph. III)

Zibotentan AstraZeneca
Prostate cancer (Ph. III)

Orteronel AstraZeneca
Prostate cancer (Ph. III)

Clodronic acid Bayer
Bone metastases (Prereg.)

Regorafenib Bayer

BiovaxID Biovest
B cell lymphoma vaccine (Ph. III)

Tovok (afatinib) Boehringer Ingelheim
Breast cancer/NSCL (Ph. III)

Vargatef (BIBF 1120) Boehringer Ingelheim
Idiopathic pulmonary fibrosis/ovarian cancer (Ph. III)

Brivanib alaninate Bristol-Myers Squibb
Liver cancer (Ph. III)

Elotuzumab Bristol-Myers Squibb/Abbott
Multiple myeloma (Ph. III)

Necitumumab Bristol-Myers Squibb/Eli Lilly

Ramucirumab Bristol-Myers Squibb
Breast cancer/CRC (Ph. III)

Satraplatin Bristol-Myers Squibb
Prostate cancer (Ph. III)

Sapacitabine Daiichi Sankyo

Tivantinib Daiichi Sankyo

Amrubicin Dainippon Sumitomo

Lenvatinib (E 7080) Eisai
Thyroid cancer (Ph. III)

MORAb-003 Eisai
Ovarian (Ph. II/III)

Enzastaurin Eli Lilly
Diffuse large B cell lymphoma/glioblastoma  (Ph.

Asparaginase EUSA Pharma
Acute lymphoblastic leukaemia (Registration)

MAGE-A3 (astuprotimut-R) GSK
Malignant melanoma (Ph. III)

Trametinib (1120212) GSK
Malignant melanoma (Ph. III)

Dabrafenib (2118436) GSK
Malignant melanoma/NSCL (Ph. III)

Trabectedin J&J
Soft tissue sarcoma (Ph. III)

V 503 Merck
HPV vaccine (Ph.

Ridaforolimus (MK-8669) Merck
Sarcoma (Prereg.)

Dovitinib Novartis
Renal cancer (Ph. III)

Junovan (mifamurtide) Novartis
Osteosarcoma (Ph. III)

Midostaurin Novartis

Panobinostat Novartis
Multiple myeloma (Ph. III)

Lucanix (belagenpumatucel-L) NovaRx

Linsitinib OSI
Adrenocortical carcinoma (Ph. III)

Axitinib Pfizer
Renal cancer (Prereg.)

Bosutinib (PF 05208763) Pfizer

Dacomitinib Pfizer

Inotuzumab ozogamicin Pfizer

GA101 (obinutuzumab) Roche
B cell lymphoma/CLL/NHL (Ph. III)

Omnitarg Roche
Breast cancer (Ph. III)

T-0MI (trastuzumab emtansine) Roche
Breast cancer (Ph. III)

Vismodegib Roche
Basal cell cancer (Prereg.)

Alvocidib Sanofi
CLL (Ph. II)

Eflornithine Sanofi
Familial adenomatous polyposis (Ph. III)

Iniparib Sanofi
Breast/NSCL (Ph. III)

Larotaxel Sanofi
Bladder cancer (Ph. III)

Omrabulin Sanofi
Sarcoma (Ph. III)

Apaziquone Spectrum Pharma
Bladder cancer (Ph. III)

Motesanib (AMG706) Takeda

TAK-700 Takeda
Prostate cancer (Ph. III)

Custirsen Teva
Prostate cancer (Ph. III)

TV-1011 Teva
Prostate/lung (Ph. III)

ch14.18 United Therapeutics
Neuroblastoma (Ph. III)

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