Realism kicks in for AMG510
Expectations for a novel lung cancer therapy being developed by Amgen were sky-high ahead of new data that was unveiled last weekend at the World Conference on Lung Cancer (WCLC).
The latest results - showing that AMG510 induced a response in 54% of patients with a KRAS mutation - will curb some enthusiasm (particularly on the investor side), but nevertheless indicate a promising approach to treating this particular genetic mutation, which had previously been thought to be 'un-druggable,' clinicians argue.
Imfinzi delivers in SCLC
Elsewhere at WCLC, AstraZeneca unveiled positive data for the combination of its PD-L1 inhibitor Imfinzi and chemotherapy as a first-line treatment for extensive-stage small-cell lung cancer (SCLC).
Roche's competing PD-L1 inhibitor Tecentriq is already approved in this setting and data from AstraZeneca's CASPIAN study confirm that immunotherapy offers an important new approach to treating SCLC.
Whether Imfinzi can overcome Tecentriq's first-to-market advantage with comparable looking data remains unclear, however. Merck & Co.'s Keytruda will also have a shot if SCLC data due to read out in late 2019 are positive.
Can Eli Lilly maximise its investment in rare cancers?
Some of the most impressive data presented at WCLC were for Eli Lilly's selpercatinib. The drug - which Eli Lilly gained via its $8-billion acquisition of Loxo Oncology - showed a 68% response rate in patients with RET fusion-positive non-small-cell lung cancer (NSCLC).
Impressive efficacy this may be, though the challenge for Eli Lilly will be identifying suitable patients; RET mutations occur in just 2% of NSCLC cases.
Acadia delivers positive update for Nuplazid
Excitement surrounding the neurology drug Nuplazid has waxed and waned in tandem with how optimistic investors have been about its potential for label expansions beyond Parkinson's disease psychosis (PDP).
Acadia Pharmaceuticals took an unexpectedly large step in the right direction this week when it announced that Nuplazid had met its primary endpoint in the Phase III HARMONY study, by significantly extending the time to relapse in patients with dementia-related psychosis (DRP). Nuplazid's success in HARMONY, if it passes muster with the FDA, could be a big deal commercially. Acadia estimates that roughly 1.2 million patients are diagnosed with DRP in the US alone.
ICER adds another angle to Novo Nordisk's pricing debate
The Institute for Clinical and Economic Review (ICER) published draft findings this week that conclude that Novo Nordisk's as-yet-approved GLP-1 agonist oral semaglutide will be less cost effective than other oral agents - positioned within the SGLT-2 and DPP-4 inhibitor classes - if the Danish company is to price oral semaglutide on a par with its injectable GLP-1 agonist Ozempic.
Novo Nordisk's pricing strategy is a key talking point ahead of regulatory action, which is expected to take place in the next few weeks. Oral semaglutide has been identified as analysts as one of 2019's standout new drug approvals in the US market.
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