miércoles, 16 de diciembre de 2015

THE PIPELINE REPORT 2016 (II): Oncology

Atezolizumab Roche 

Indication: Bladder; breast; renal; NSCLC (Ph.III) 
What the clinical trials found: A Phase-II study (POPLAR) met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy (HR = 0.54; p = 0.014) in people with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. AEs were consistent with previous studies. 
Credit Suisse Success Probability: 75%. Expected launch: 2016 (Source: Credit Suisse) 
Credit Suisse forecast: $4.45 billion in global sales by 2020 
What the physicians are saying: While a latecomer to the immunotherapy party, atezolizumab represents a new modification of current immunotherapies in that it targets PD-L1 (rather than PD-1), which is hypothesized to have less off-target toxicity. Urothelial bladder cancer (UBC), in particular, has not seen significant development in decades so any new treatment modalities would be welcome for patients and physicians. A biomarker driven approach in tumors such as NSCLC is well established and PD-L1 testing might be able to smoothly integrate. —Alex Bastian, VP, GfK Health 

Abemaciclib Eli Lilly 

Indication: NSCLC; breast cancer (Ph.III) 
What the clinical trials found: A Phase-I trial of abemaciclib found a 49% disease control rate for the 57 evaluable patients with NSCLC, including 2 partial responses and 26 patients with stable disease. The disease control rate for the KRAS-mutant patients was 55% vs. 38% for the KRAS wild-type patients. Leukopenia and neutropenia were the most common grade 3 AEs reported. No grade 4 AEs occurred. 
Credit Suisse Success Probability: 65%. Expected launch: 2018 (Source: Credit Suisse) 
Credit Suisse forecast: $550 million in global sales by 2020 
What the physicians are saying: Abemaciclib is the only CDK inhibitor that has shown promise as a single agent, leading to Breakthrough Therapy designation (in refractory HR+ advanced or metastatic breast cancer). On a pharmacologic basis, this could be best in class. Pfizer's Ibrance (palbociclib) has helped to introduce the drug class into the treatment paradigm. Most patients will be treated with a CDK inhibitor. Other drugs in the class have a week off due to AEs (neutropenias). With abemaciclib, you wouldn't need to stop treatment. —Alex Bastian, VP, GfK Health 

 ABP-215 (bevacizumab biosimilar) Amgen/Allergan 

Indication: Advanced NSCLC (Ph.III) 
What the clinical trials found: In a Phase-III study, the primary endpoint, overall response rates (ORR), was within the pre-specified margin for ABP-215 compared to bevacizumab, showing clinical equivalence. The secondary endpoints, risk difference of ORR, duration of response and progression-free survival were consistent with the primary endpoints. Safety and immunogenicity of ABP 215 were comparable to bevacizumab. What the analysts are saying: Branded Avastin (bevacizumab) had sales of $3.3 billion in 1H15, representing a huge opportunity for a biosimilar copy. This agent will provide an alternative for the cost-conscious US physician and payer community. Easier access to bevacizumab could be a welcome addition but this depends on how payers integrate biosimilars into formularies and pathways. Another unanswered question: whether this agent can get all Avastin indications. —Alex Bastian, VP, GfK Health


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