The Pipeline Report 2014: Class Seekers

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The Pipeline Report 2014: Class Seekers
The Pipeline Report 2014: Class Seekers



Nivolumab Bristol-Myers Squibb
Indication: NSCLC/melanoma/RCC (Ph. III)
What the clinical trials found: Durable response across all three tumors in the heavily pre-treated. Nivolumab + Yervoy melanoma combo trial showed 53% response rate—additive over each agent alone. Looks to be extremely well-tolerated.
inThought Approvability Index and Comment: 57%. The anti-PD1 compounds from BMS, which won fast-track designation in three tumor types, and Merck, which received the FDA's breakthrough designation for treating melanoma, are vying for pole position in what looks to be an important new approach to cancer care, immuno-oncology (I/O). If it turns out that Merck has it and BMS doesn't, that will prove whether breakthrough status makes a difference. Expected launch: for both compounds: Mid-2015 (Source: Symphony Health Solutions)
Leerink Swann revenue forecast: $7-17B US/$14-34B WW opportunity by 2025 for I/O, with 45% going to first-to-market BMS, 25% to Roche, 20% to Merck, 10% to AstraZeneca
What the analysts are saying: In melanoma, these drugs are replacing chemo; the real buzz is around long-term cure. We could boost it higher than Yervoy's 20% long-term cure rate. And I/Os, which skirt the resistance that often develops with targeted molecular therapeutics, may compete in BRAF-mutant populations with inhibitors of BRAF (Roche's Zelboraf, GSK's Tafinlar) and MEK (GSK's Mekinist). —Stephanie Hawthorne, PhD, director, Kantar Health

LDK 378 Novartis
Indication: NSCLC (Phase III)
What the clinical trials found: 60% ORR in a Phase I trial of patients with ALK+ NSCLC, including patients who had received crizotinib therapy (ORR of 59%) and patients who were crizotinib-naïve (ORR of 62%); 47 out of 78 patients showed partial responses.
inThought Approvability Index and Comment: 88%. This oral drug looks to be a viable back-up to Pfizer's Xalkori (crizotinib), the first ALK inhibitor but one which (like many molecular targeted drugs) encounters resistance. It could also compete to be a first-line choice. We're just scratching the surface with ALK inhibition. Given the resistance issue, we need more than two drugs in that class, which is no problem because Roche, Ariad and several others are lining up hopefuls. Expected launch: 2016 (Source: Credit Suisse)
Credit Suisse revenue forecast: $374 million in global annual sales by 2020
What the analysts are saying: The Phase-I data showing 50% ORR in Xalkori-naïve and 67% in the Xalkori-resistant reflect about the same level of benefit. LDK 378 may not be stronger than Xalkori, but it doesn't lose efficacy (i.e., remains effective) when used post-Xalkori, which will be important for its launch. The compound received breakthrough therapy designation, and Novartis aims to file it in early 2014. The Chugai/Roche ALK inhibitor had good data, but I don't hear as many people talking about that one. For oncologists who have patients with the ALK mutation, these will be important, but ALK is only 3% of lung cancer. —Stephanie Hawthorne, PhD, director, Kantar Health


Elotuzumab AbbVie
Multiple myeloma (Ph.III)

T-VEC Amgen
Mal. melanoma (Ph.III)

Trebananib/AMG-386 Amgen
Ovarian (Ph.III)

AP 26113 Ariad

Moxetumomab pasudotox  AZ
Hairy cell leukemia (Ph.III)

Solid tumors (Ph.I)

Nintedanib Boehringer Ingelheim

Volasertib Boehringer Ingelheim
Various cancers (Ph.III)

BMS-936559 BMS
Solid tumors (Ph.I)

Elotuzumab BMS
Multiple myeloma (Ph.III)

Necitimumab Eli Lilly

LY-2835219 Eli Lilly
Cancer (late-stage) (Ph.II)

Ramucirumab Eli Lilly
Gastric (Pre-reg.)

Idelalisib Gilead
NHL (Pre-reg.)


ARN-509 J&J
Prostate cancer (Ph.III)

Siltuximab J&J
Multicentric casteman's dis. (Pre-reg.)

Yondelis J&J
Sarcoma/ovarian (Ph.III)

MK3475 Merck
Mal. Melanoma (Ph.III)

Vintafolide Merck
Ovarian (Pre-reg.)

LBH589 Novartis
Multiple myeloma (Ph.III)

LDE225 Novartis

LDK378 Novartis

S-1 Otsuka
Gastric (Ph.III)

Dacomitinib Pfizer

Palbociclib Pfizer
Breast (Ph.III)

Inotuzumab Pfizer

Alectinib Roche

Onartuzumab Roche
Gastric/NSCLC (Ph.III)

Cobimetinib combo Roche
Mel. (BRAF) (Ph.III)

MPDL-3280A Roche

TAK-700 Takeda
Prostate (Ph.III)

MLN9708 Takeda
Mult. myeloma (Ph.III)

MLN8237 Takeda
Lymphoma (Ph.III)

StemEx Teva
Cancer (Ph.III)

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