ASCO15: Bristol-Myers Squibb Cancer Drug Combo Shrinks 60% of Melanomas, As Oncology Roars

ASCO15: Bristol Myers Cancer Drug Combo Shrinks 60% of Melanomas, As Oncology Roars
June 2, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

A new drug combo from Bristol-Myers Squibb Company showed shrinkage in 60 percent of melanomas and stopped that cancer from progressing for nearly a year in 58 percent of 945 patients being treated, the company told the American Society of Clinical Oncology (ASCO) this week.

The combo of cancer drugs ipilimumab and nivolumab was used in an international trial and showed tumors in patients studied remained stable or shrank 58 percent of the time for an average of 11.5 months. That’s a major boost from treatment with ipilimumab alone, which affected tumors only 19 percent of the time for 2.5 months. Side effects included fatigue, rash and diarrhea for around half of the patients tested, a much higher number than those using ipilimumab by itself.

The results were published simultaneously in the New England Journal of Medicine and had oncology experts delighted Monday.

"By giving these drugs together you are effectively taking two brakes off the immune system rather than one so the immune system is able to recognize tumors it wasn't previously recognizing and react to that and destroy them,” James Larkin, a consultant at the Royal Marsden Hospital and a lead British investigator, told BBC News.

"For immunotherapies, we've never seen tumor shrinkage rates over 50 percent so that's very significant to see. This is a treatment modality that I think is going to have a big future for the treatment of cancer."

The eyes of the biotech and life sciences world are all fixed on ASCO, which began last Friday. The world's biggest cancer research conference, ASCO, puts out about 5,000 datasets known as the “abstract drop,” as it prepares reporters, investors and market participants for what to expect from presenters at this year’s gathering.

That flood of cancer drug data can sometimes be overwhelming, but Wall Street and scientists alike wait eagerly for what could be the next big thing in cancer treatment.

Also notable was Bristol-Myers Squibb’s (BMY) abstract for its CHECKMATE 057 trial, a Phase III study of Opdivo versus chemotherapy in second line non-squamous lung cancer, has Wall Street pondering.

“The key point after reviewing today's abstract: Tumors with low PDL1 expression do not appear to derive a benefit from Opdivo over docetaxel (unlike in CHECKMATE 017),” wrote closely watched biotech analyst Mark Schoenebaum with ISI Evercore in a late breaking note Friday.

“Otherwise stated, the hazard ratios for tumors with low PDL1 expression are all close to 1,” he explained. “Having a survival hazard ratio of 1 relative to docetaxel is not necessarily a bad thing to the extent that Opdivo may be better tolerated than docetaxel and there still may be the hope for a person taking the drug to be part of the ‘tail’ that may come with immunotherapy.”

ASCO information from BMY for CHECKMATE 017 has its caveats however, cautioned Schoenebaum.

“But the data raises questions, including whether patients with non-squamous lung cancer in the second line setting would (rather than simply just taking Opdivo) want to have their tumor tested for PDL1 expression before starting PD1 or PDL1 antibodies,” he wrote in a note to investors.

“In such a scenario, if a patient is willing to undergo a biopsy (which has some risk--small but real) the possibility arises that patients choose a diagnostic assay and antibody from a different company, such as MRK and Roche ,” said Schoenebaum. “BMY, however, appears to have also shown, much like MRK and Roche, that those with high PDL1 expression appear to have a meaningful benefit with hazard ratios as low as ~0.4-0.6. Based on BMY's assay, ~40-55 percent of patients fall into this category of positive PDL1 expression.”

Schoenebaum said that prior to today, expectations after CHECKMATE 017 data were that Opdivo in CHECKMATE 057 would similarly show a “meaningful benefit” over docetaxel even for patients with low PDL1 expression.

“And that in some senses BMY had likely ‘won’ second line by working across both squamous and non-squamous lung cancer types and tumors independent of PDL1 expression,” said Schoenebaum. “Today's abstract, however, appear to open the door to competitors in the 2nd line setting (such as MRK and Roche) who are a little further behind but are expected to file soon with data also demonstrating good activity in tumors that highly express PDL1+. The debate may then come down to finer details of the data and the diagnostic assays.”



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?

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