The Pipeline Report 2013: Late-Stage Standouts

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The Pipeline Report 2013: Late-Stage Standouts
The Pipeline Report 2013: Late-Stage Standouts

Oncology

PRODUCTS GENERATING BUZZ
BMS-936558 Bristol-Myers Squibb
Indication: NSCLC/melanoma/RCC (Phase III)
What the clinical trials found: Overall response rates of 28% in melanoma, 18% in non-small cell lung cancer, and 27% in renal cell carcinoma in Phase I. The drug looks to be extremely well-tolerated, with low rates of immune-related adverse events.
inThought Comment: Use of this anti-PD-1 monoclonal antibody is gaining fans, given tumor shrinkage rates. While data are limited, response rates seen so far—15-30% in heavily refractory patients—suggest the anti-PD1 approach is viable. Estimated approval: 2015 (Source: Symphony Health Solutions)
Revenue forecast: $2.0 billion in 2020, says Leerink Swann's ­Seamus Fernandez.
What the analysts are saying: BMS-936558 is an immuno-therapy like melanoma drug Yervoy (ipilimumab, Bristol-Myers Squibb), only better tolerated. Also exciting is the potential to have a biomarker (response may be limited to patients who overexpress PD-L1). We expect excitement for trials and for patients to enroll rather quickly, especially given the paucity of effective options in second-line NSCLC and the novel MOA. Other PD-1 inhibitors are being developed by Teva and CureTech, GSK and Amplimmune, as well as Merck. —Stephanie Hawthorne, PhD, director, Kantar Health

T-DM1 Roche/Genentech
Indication: 2nd line metastatic HER2-pos. breast cancer (Prereg.)
What the clinical trials found: In Phase III, patients had a statistically significantly longer PFS (9.6 vs. 6.4 mos.) vs. GlaxoSmithKline's Tykerb plus Roche's Xeloda. Interim OS analysis suggested a 38% reduction in the risk of death. T-DM1 is also very well tolerated.
inThought Approvability Index and Comment: 81%. T-DM1 packages Herceptin (trastuzumab) with a chemotherapy, DM1 (emtansine), with the goal of targeting to breast cancer cells that express HER2. The road to approval has been long and hard (T-DM1 has been in development since 2001), but Genentech finally seems to be on track. Estimated approval: 1Q13 (Source: Symphony Health Solutions)
Revenue forecast: CHF 623 ($660 million) in annual revenue in 2016, says Bernstein's Tim Anderson.
What the analysts are saying: T-DM1 is well-positioned to displace Tykerb/Xeloda in previously-treated mBC patients. We expect T-DM1 to be quickly adopted as a new standard of care in second- and third-line mBC, and eventually for it to move into the first-line setting (it's currently being studied in the Phase III MARIANNE trial in this indication). Genentech and Roche have a strong reputation in the HER2+ mBC space, with Herceptin entrenched, Perjeta (pertuzumab) recently approved for use in combination with Herceptin/chemotherapy in first-line mBC, and T-DM1 now poised to enter. We expect a premium price over Herceptin. —Stephanie Hawthorne, PhD, director, Kantar Health

OTHER KEY PRODUCTS IN THE PIPELINE

Linifanib Abbott
Liver cancer (Ph. III)

Talimogene Amgen
Malgnant melanoma (Ph.III)

Trebananib Amgen
Fallopian tube cancer (Ph.III)

Zibotentan/AZD4054 AstraZeneca
Prostate (Ph.III)

Alemtuzumab Bayer
CLL (Ph.III)

Brivanib BMS
Liver cancer (Ph.III)

Elotuzumab BMS
Multiple myeloma (Ph.III)

Necitumumab BMS
NSCL (Ph.III)

Afatinib Boehringer Ingelheim
Breast cancer (Ph.III)

Nintedanib Boehringer Ingelheim
NSCL (Ph.III)

Amrubicin Celgene
NSCL (Ph.III)

Azacitidine Celgene
AML (PH.III)

Pomalidomide Celgene
Multiple myeloma (Prereg.)

Denileukin diftitox Eisai
Bone metastases (Prereg.)

Lenvatinib Eisai
Thyroid cancer (Ph.III)

Farletuzumab Eisai
Ovarian cancer (Ph.III)

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

Dabrafenib GSK
Malignant melanoma (Prereg.)

Dabrafenib-trametinib GSK
Malignant melanoma (Ph.III)

Trametinib GSK
Breast cancer (Ph.III)

Enzastaurin Eli Lilly
B cell lymphoma (Ph.III)

Ramucirumab Eli Lilly
Gastric/breast/CRC (Ph.III)

Ibrutinib J&J
CLL (Ph.III)    

Trabectedin J&J
Breast/ovarian cancer (Ph.III)

MK 7965 Merck
CLL (Ph.III)

MK 8109 Merck
Ovarian cancer (Ph.III)

MK 8669 Merck
Sarcoma (Prereg.)

BKM 120 Novartis
Breast cancer (Ph.III)

Dovitinib Novartis
Renal cancer (Ph.III)

Midostaurin Novartis
AML (Ph.III)

Mifamurtide Novartis
Osteosarcoma (Ph.III)

Panobinostat Novartis
Malignant melanoma (Ph.III)

Signifor Novartis
Carcinoid tumors (Ph.III)

Azacitidine Pfizer
AML (Ph.III)

Inotuzumab/PF 5208773 Pfizer
NHL (Ph.III)

GA 101/RG 7159 Roche
B cell lymphoma (Ph.III)

Onartuzumab Roche
NSCL (Ph.III)

Iniparib Sanofi
Breast cancer (Ph.III)

Ombrabulin Sanofi
Soft tissue sarcoma (Ph.III)

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