ASCO15: Tiny Clovis Oncology Becomes an Even Bigger Takeover Target as Ovarian Cancer Drug Shrunk Tumors in 82% of Women
June 1, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Boulder, Colo.-based Clovis Oncology has become an even more attractive takeover target after it presented data Saturday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago that showed its ovarian cancer drug shrunk tumors in 82 percent of the women it treated in a recent mid-stage trial.
All of the patients treated with Clovis' rucaparib during the Phase II ARIEL2 had a mutated BRCA gene and 10 percent of patients had complete resolution of their tumors. Median progression-free survival was 9.4 months. In addition, nearly half of those (45 percent) with "BRCA-like" saw response rates to rucaparib, with their median progression-free survival in these patients was 7.1 months.
The news was helpful for Clovis because it offset a later, disappointing announcement that showed lackluster results for its non-small cell lung cancer rociletinib—and set up a war with much large competitor AstraZeneca PLC , who presented its own stunning lung cancer drug results yesterday.
“With these data presented at ASCO, we believe rucaparib has clearly emerged as a unique and best-in-class PARP inhibitor," said Patrick J. Mahaffy, president and chief executive of Clovis Oncology in a statement.
"In addition, with our now clinically proven BRCA-like clinical assay, we have validated our commitment to develop rucaparib not only for the 25 percent of women with germline and somatic BRCA mutations, but for the additional approximately 35 percent of women with the prospectively identified BRCA-like signature,” he said. “With the ARIEL2 extension enrolling rapidly, we look forward to submitting our NDA for rucaparib for the treatment of advanced ovarian cancer next year."
Rumors that Clovis could soon exit to a larger suitor have been swirling for months now, but this week’s ASCO data is likely to rejuvenate them. The company is in a better position now to entertain potential suitors than it was in 2013, after a Goldman Sachs Group Inc. analyst, Terence Flynn, said in a note in late April that there’s at least a 30 percent chance the $2.9 billion Clovis will be acquired.
Now, with both of Clovis’ lung and ovarian cancer therapies receiving breakthrough status by the U.S. Food and Drug Administration (FDA), it’s only a matter of time before larger companies come calling.
“It’s fairly noteworthy that a small biotech gets breakthrough designation on two of their products,” Jon Loth, a money manager for Nuveen Asset Management’s Small Cap Growth Opportunities fund, told the Bloomberg in April.
Also of note? Big partnership deals inked by Clovis in the intervening two years. Biotech giant GlaxoSmithKline LLC (GSK) said in November it will partner with the scrappy Clovis on a new Phase I/II trial of an experimental oral combination therapy targeting mutant epidermal growth factor receptor (EGFR) in non-small cell lung cancer.
The trial to test the combo of rociletinib and trametinib is planned for the first half of 2015. It will primarily test the safety and activity of the combination in patients with EGFR mutant NSCLC who were previously treated with an EGFR tyrosine kinase inhibitor (TKI).
“We have seen significant activity in EGFR mutant NSCLC patients treated with rociletinib monotherapy, and so an important next step in our research is to examine rociletinib in combination with other targeted therapies that may also impact acquired resistance to EGFR inhibitors,” said Lecia Sequist, the lead investigator for the study and medical doctor at Massachusetts General Hospital Cancer Center and associate professor of Medicine at Harvard Medical School.
All patients with EGFR mutant NSCLC eventually develop resistance to EGFR TKI therapy, said Clovis, with the T790M gene usually the primary resistant mutation, cropping up in 60 percent of patients treated with first- and second-generation EGFR inhibitors.
“We’ve seen a sufficient amount of data to whet the appetite but we really haven’t seen a large enough sample size to say 'OK, you know what? This is definitely a consistent effect and this drug really appears to be working in this unmet need,'" Brian Klein, a New York-based analyst at Stifel Financial Corp, told Bloomberg. “But management certainly has a history of selling a company at a time that is most beneficial for investors and I would say that they would probably pursue that route again.”
Rociletinib is designed to target the T790M and the activating mutations of EGFR (L858R and Del19). So far, it has shown some success in clinical activity and tolerability in Phase I/II studies of patients with EGFR mutant NSCLC.
Trametinib inhibits mitogen-activated protein kinase (MEK), which determines MAPK pathway signaling, thus inhibiting growth factor-mediated signaling and cellular proliferation.
Combining the two shows an enormous amount of potential, said executives at Clovis, even if initial ASCO data for rociletinib was mediocre. Trametinib has already been approved by the U.S. Food and Drug Administration (FDA) as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?