AstraZeneca ($AZN) executives showed up at ASCO under some extreme pressure to perform. In order to wriggle out of Pfizer's ($PFE) grasp, the company's CEO promised a near-term, megablockbuster future for its new cancer drug pipeline. And its oncology team aggressively hit the floor in Chicago, publicly brimming with confidence about its top prospects, with global plans to quickly expand its cancer pipeline into an industry leader with multiple combination therapies being pushed into the clinic.
The pharma giant didn't actually announce anything particularly dramatic--not surprising after just rushing out every bit of positive information available to disentangle itself from the $120 billion buyout offer--but execs offered a blueprint of plans to build up its late-stage cancer pipeline. And they hammered hard on common themes like rapid progress, bold vision and momentum.
On Tuesday morning, the pharma giant followed up by offering its first snapshot of results from a small, early-stage study of MEDI4736, its would-be PD-L1 immuno-oncology star. In a Phase I dose-escalation study in 27 patients with advanced solid tumors, MEDI4736 triggered a reduction of tumor burden in as early as 6 weeks, investigators noted: "Clinical activity was maintained for at least one year, with 19% of patients achieving a partial response and 39% of patients achieving disease control."
AstraZeneca had said earlier that AZD9291, its promising targeted therapy for non-small cell lung cancer, was already expected to get into the hands of regulators by the second half of next year. Now the pharma giant says that application could arrive as early as Q1 2015, adding pressure on Clovis's plans for its rival drug CO-1686. Execs also touted the advance of a combination of olaparib and cediranib into Phase III, announced they were expanding a Phase II trial for tremelimumab into a registration study for mesothelioma and talked up a decision to add a combination of its immuno-oncology drug MEDI4736 (PD-L1) with tremelimumab (CTLA-4) in Phase III for NSCLC.
By next year's ASCO, says Ed Bradley, head of innovative medicines at MedImmune, you can also expect to see a much larger cancer drug pipeline. There are plans to add two new molecular entities to their pipeline with a special focus on T cells; with one drug that takes the brakes off the immune system and another that hits the gas pedal on immune response. And he promised a full slate of combination trials for drugs that address a wide variety of targets in oncology, adding a program for the tumor microenvironment and "at least" 4 NMEs for innate immunity and antigen presentation over the next 12 to 18 months.
Monotherapies are great, he adds, but "combinations that address the multiple blockade that cancer cells exhibit is much more likely to be effective." Among those combo studies, says Bradley, AstraZeneca is looking to add a match of PD-L1 and PD-1 drugs, the complementary immune system pathways that have attracted so much attention in recent years.
"It's a growing portfolio," says Bradley, adding that "this portfolio allows us to get more quickly to the end game."
Going into ASCO, AstraZeneca's public projections on peak sales, trial performance and speed of action were already well ahead of even the most optimistic forecasts by analysts. It's now provided an additional yardstick that will be used to measure its performance for years to come.
- here's the release on MEDI4736
- here's the release from AstraZeneca
- here's the presentation on the pipeline