While Bayer AG has no headline-making data to report at the American Society of Clinical Oncology’s annual meeting, it will be talking to a potential partner about development of a new combination with one of its drugs.

“Where there are rational combinations for biology we are absolutely for putting them together,” David Weinreich, Bayer’s head of global clinical development oncology, stated at a May 9 media briefing in New York. He noted that Bayer would have one of those conversations at ASCO with an undisclosed company.

“Most of the big companies do these all behind the scenes because nobody has everything they could possibly want in the portfolio,” he said. “And at a fundamental level we are all after exactly the same thing, which is to get the right patient group” to cure this disease.

[Editor’s note: It appeared from the briefing discussion that Weinreich was referring to a product to be used in combination with one of Bayer’s. Bayer subsequently announced a deal with Orion Corp. to develop and commercialize Orion’s novel oral androgen receptor inhibitor ODM-201 for treatment of prostate cancer ([A#00140609018])].

Bayer met with the press in advance of ASCO’s May 30-June 3 meeting in Chicago to emphasize its commitment to oncology and its desire to become a leading player in the field. Nearly a decade after entering the sector, it now has three products on the market, two additional candidates in Phase II trials and a dozen more in Phase I testing. Bayer is developing two of the Phase I compounds in collaboration with OncoMed Pharmaceuticals Inc., another in collaboration with Amgen Inc. and a fourth in collaboration with ImmunoGen Inc. (see chart).

Weinreich said that even if half or three quarters of the compounds in development fail, Bayer expects to end the decade with six or seven assets on the market. It has a long way to go, however, to join the ranks of the major oncology players, led by Roche and Novartis AG Also see "Pfizer Oncology: Big Strides But Not Blockbuster Size" - Pink Sheet, 27 May, 2013..

Failed Nexavar Liver Cancer Study Provides “Rich Data Set”

Nexavar (sorafenib), Bayer’s first oncology drug, was approved in December 2005 for treatment of renal cell cancer and subsequently approved for treatment of liver and thyroid cancer. The drug is now in a Phase III study comparing Nexavar in combination with capecitabine versus capecitabine alone in metastatic HER2-negative breast cancer patients.

Bayer launched Stivarga (regorafenib) in the fourth quarter of 2012 for colorectal cancer and subsequently obtained approval for treatment of gastrointestinal stromal tumors. And it launched Xofigo (radium-223 dichloride) in May 2013 for castration-resistant prostate cancer. The drug is now in a Phase III trial for treatment of colorectal cancer and a Phase III study for treatment of patients with liver cancer who have progressed on Nexavar.

In the first quarter of 2014, Nexavar produced sales of €183 million and Stivarga had sales of €54 million. Since its launch, Xofigo has posted sales of €36 million.

Weinreich said the most important presentations at ASCO will be the topline results of its unsuccessful Phase III study of Nexavar in liver cancer and Phase I data for its phosphatidylinositol 3-kinase (P13K) inhibitor copanlisib, which Bayer regards as one of its most promising assets ([A#14140506007]).

Bayer and its partner Onyx Pharmaceuticals Inc. announced in March that the STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) study did not meet its primary endpoint of improving recurrence-free survival. An ASCO abstract notes that a total of 1,114 patients were randomized to receive sorafenib or placebo and no differences were observed between the two groups in recurrence-free survival, time to recurrence and overall survival.

From an informational perspective, “you can’t knock a massive Phase III study in an indication that has never been studied before,” Weinreich said. “It didn’t work but it is a rich data set to potentially help ask questions not just about Nexavar, but questions also about the natural history of the disease.”

Bayer also will present the results of a Phase I dose escalation study of copanlisib in combination with gemcitabine or gemcitabine-cisplatin in advanced cancer patients. The abstract states that both combinations are generally well tolerated and that an early efficacy signal was seen in patients with biliary tract cancer (BCT). Of the two patients with BCT who received cisplatin, gemcitabine and copanlisib, one achieved a complete response and one a partial response.

The company will also report the results of a Phase Ib trial of copanlisib combined with Bayer’s allosteric-MEK inhibitor refametinib in patients with advanced cancer. The abstract notes that dual inhibition of the P13K and MAPK signaling pathways is a promising strategy for optimal anticancer therapy. The study found that the copanlisib-refametinib combination was generally well tolerated, with the maximum tolerated dose and recommended Phase II dose below the individual tolerated doses of either compound. Preliminary evidence of clinical efficacy also was observed.

Other Phase I compounds in the pipeline include two drugs developed by OncoMed (vantictumab and OMP-54F28) that block the Wnt signaling pathway. Weinreich said the goal is to block the cycle through this pathway and thereby induce a cancer stem cell to differentiate. He said that if this works the compounds will stop stem cells from being resistant to cytotoxic therapies and induce them to divide, making them more susceptible to cytotoxics. OncoMed, which is evaluating the compounds in chemotherapy combination safety studies, will present data at ASCO. Bayer has the option to take them over for Phase II development.

Bayer Oncology Portfolio
Stage	Drug Asset
Approved	Nexavar (sorafenib) Advanced renal cell carcinoma; unresectable hepatocellular carcinoma; differentiated thyroid carcinoma
	Xofigo (radium-223 dichloride) Castration-resistant prostate cancer
	Stivarga (regorafenib) Metastatic colorectal cancer; gastrointestinal stromal tumor
Phase III	Nexavar as adjuvant in metastatic HER-2 negative breast cancer (RESILIENCE trial)
	Xofigo in combination with abiraterone acetate and prednisone/prednisolone for treatment of asymptomatic or mildly symptomatic patients with bone-predominant metastatic castration resistant prostate cancer who have not received chemotherapy
	Stivarga in patients with colorectal cancer after resection of liver metastases (COAST trial) Stivarga in patients with hepatocellular carcinoma who have progressed on Nexavar (RESORCE study)
Phase II	Copanlisib (BAY 80-6946) (P13K inhibitor) for treatment of recurrent/resistant non-Hodgkin’s lymphoma
	Xofigo in patients with hormone refractory prostate cancer and breast cancer
	Stivarga in patients with hepatocellular carcinoma, renal cell carcinoma and colorectal cancer
	Refametinib (BAY 86-9766) (MEK inhibitor) in RAS mutant hepatocellular carcinoma; one trial as single agent and another in combination with sorafenib
Phase I	Copanlisib
	BAY 1082439 (P13K inhibitor)
	Roniciclib (BAY 1000394)
	Refametinib
	Anetumab ravtansine (BAY 94-9343), in collaboration with ImmnoGen
	Vantictumab (OMP-18R5), in collaboration with OncoMed
	OMP-54F28, in collaboration with OncoMed
	BAY 2010112, in collaboration with Amgen
	BAY 1163877
	BAY 1179470
	BAY 1143572
	BAY 1125976

Bayer Looks For New Partner As It Strives To Be A Player In Oncology Market

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