Investors Wait With Bated Breath for ImmunoGen's Ovarian Cancer Drug ASCO News
May 28, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Investors are waiting with bated breath for updated data from ImmunoGen, Inc. on its experimental cancer drug IMGN853 to be presented on Saturday at the American Society of Clinical Oncology (ASCO) in Chicago—particularly since the company’s abstract two weeks ago showed four of the first 10 patients treated with the drug appeared to benefit.
ImmunoGen has already said it will begin a new trial of IMGN853 in ovarian cancer patients by the end of 2015. That has both analysts and investors champing at the bit to know just how well the company is doing in these mid-stage trials.
An analyst with RBC Capital Markets, Simos Simeonidis, said that they remain bullish on ImmunoGen because the data on IMGN853 looks so promising.
“To date, 14 patients with platinum-resistant epithelial ovarian cancer (EOC) have been treated at the recommended Phase II dose (RP2D), with two in dose escalation and 12 in the expansion cohort,” he wrote in a note to investors this month. “All patients in the trial were heavily pretreated, with a mean of 4.5 and a range of 2–12 prior treatments. In addition, all patients had prior exposure to taxane treatment and all of them had progressed on their most recent treatment regimen. IHC (immunohistochemistry) analysis demonstrated that all patients had FRalpha-positive tumor expression.”
Those results showed a benefit observed in 5/10 of evaluable patients (4/14 patients have not yet reached their first assessment), with 4 PRs and 1 CA125 response, yielding an ORR of 40% and clinical benefit rate of 50 percent. In each PR, it was observed that tumor regression had begun early on treatment (cycle 2 evaluation), said Simeonidis.
“Furthermore, shrinkage of visceral metastases was reported, with a PR patient exhibiting a 45 percent reduction in a 5 cm liver mass,” he noted. The “majority” of AEs were grade 1 or 2, with diarrhea, ocular events, cough, fatigue, decreased appetite, neuropathy and nausea reported to occur in greater than 20 percent of patients. Study enrollment continues and nine of 14 patients remain on study.
“Our take on the data: With the caveat that these are data from an open label trial and represent a very small dataset of just 10 patients, we view them as promising. The 40 percent ORR and 50 percent CBR, together with what seems to be a benign safety and tolerability profile, bode well for IMGN853. Management previously stated a benchmark response rate in PROC of 30– 40% in addition to 7–8 months of duration. Based on this early data, IMGN plans to move ahead to a potentially registrational program for '853 in PROC.”
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?