ASCO15 EXCLUSIVE: Late-Breaking Bristol-Myers Squibb Data Renew Tumor Drug Hopes

Published: Jun 01, 2015

ASCO15: Late-Breaking Bristol-Myers Squibb Data Renew Tumor Drug Hopes
May 29, 2015
By Riley McDermid, BioSpace.com Breaking News Staff

Four late-breaking abstracts on immunotherapy have been released ahead of the American Society of Clinical Oncology (ASCO)’s annual meeting and analysts are scrambling Friday to make sense of what they could mean.

Most notably, Bristol-Myers Squibb’s 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.”

The eyes of the biotech and life sciences world are all fixed on ASCO, starting today, May 29, and running through June 2. 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 presenter’s at this year’s gathering. The 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.

Today’s information from BMY 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.”

Below CHECKMATE-057 abstract:

Nivolumab Checkmate-057 - phase 3 in non-squamous NSCLC

Background: Options for advanced non-SQ NSCLC patients (pts) who progress after platinum-based doublet chemotherapy (PT-DC) are limited, with minimal improvement in overall survival (OS). We report results from a randomized, global phase III study of NIVO, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, vs DOC in pts with advanced non-SQ NSCLC after failure of PT-DC and tyrosine kinase inhibitor, if eligible. Methods: Pts were randomized to NIVO 3 mg/kg Q2W (n=292) or DOC 75 mg/m2 Q3W (n=290) until progression or discontinuation due to toxicity/other reasons. Primary objective was OS; Secondary objectives were investigator-assessed objective response rate (ORR; per RECIST v1.1), progression-free survival (PFS), efficacy by PD-L1 expression, quality of life, and safety. Results: NIVO demonstrated superior OS (HR=0.73; 96% CI: 0.59, 0.89; P=0.00155) and improved ORR (19.2% vs 12.4%; P=0.0235). HR for PFS was 0.92 (95% CI: 0.77, 1.11; P=0.393). PD-L1 expression was associated with benefit from NIVO (Table). In PD-L1+ pts, NIVO showed improved efficacy across all endpoints at predefined 1%, 5%, and 10% cut- points. Grade 3-5 drug-related AEs occurred in 10.5% (30/287) of NIVO and 53.7% (144/268) of DOC pts. No deaths were related to NIVO vs 1 DOC-related death. After discontinuation, 42.1% of NIVO and 49.7% of DOC pts received subsequent systemic therapy. Conclusions: NIVO demonstrated superior OS vs DOC in pts with advanced non-SQ NSCLC after failure of PT-DC. The safety profile of NIVO 3 mg/kg Q2W was favorable vs DOC. NIVO demonstrated survival benefit across histologies in two randomized phase III trials. Clinical trial information: NCT01673867.

ASCO15: Late-Breaking Bristol-Myers Squibb Data Renew Tumor Drug Hopes




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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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