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Collaboration With Bristol Myers Squib Led to Successful Launch of Ono Pharmaceutical’s Cancer Immune Therapy (Opdivo®)

Posted in Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, Immuno-Oncology & Genomics, Monoclonal Immunotherapy, tagged #endcancer, Bristol-Myers Squibb, Cancer - General, cancer immunotherapeutics, opdivo on March 4, 2016| Leave a Comment »

Collaboration With Bristol Myers Squib Led to Successful Launch of Ono Pharmaceutical’s Cancer Immune Therapy (Opdivio®)

Reporter: Stephen J. Williams, Ph.D.

Updated 7/25/2019

Below are excerpts and a great story on the origins on Opdivo and its early marketing troubles and eventual success when Bristol Myers partnered with a small Japanese pharma, Ono Pharmaceuticals.

As seen in Biospace News

Ten years ago, representatives from Japan’s Ono Pharmaceutical Co. went from hospital to hospital, attempting to convince doctors to test a new product under development: drugs that helped the body’s immune system fight cancer. Nobody would listen.

Immuno-therapy was another fad, they were told. The treatment probably offered no bigger benefit than eating mushrooms to fight cancer, one critic opined. Another said he’d shave his head if it worked.

Read at Bloomberg

Source: http://www.biospace.com/News/how-a-150000-drug-created-with-bristol-myers/411159/source=TopBreaking

From Bloomberg

This $150,000 Cancer Treatment Saved a Pharma Company

By Natasha Khan natashakhanhk

Ono’s Chief Executive Officer Gyo Sagara says he received plenty of apologies when Opdivo, the drug the Japanese company worked on with Bristol-Myers Squibb Co., got the green light from regulators. The drug’s approval in Japan 20 months ago was the first worldwide in a new class of cancer treatments called PD-1 inhibitors.

It is among a string of therapies coming to market in the immuno-oncology category – medicines that help the body combat cancer rather than directly attacking the cancer cells themselves. The influential Science journal called cancer immunotherapy the “breakthrough of the year” in 2013, and the biggest global pharmaceutical companies are rushing into the field.

“They found the treasure of the century,” said Fumiyoshi Sakai, a health-care analyst with Credit Suisse, who boosted his target price for the stock to 25,000 yen in mid February. Ono’s shares closed at an all-time high of 22,605 yen on Thursday after climbing more than 70 percent over the past year.

The drug is pumping fresh life into Ono, which for years has battled slumping sales, patent expirations and rising competition from cheaper generics. Analysts now forecast that the Japanese company — among the biggest makers of specialty pharmaceuticals in Asia with a market cap of about $23 billion — will more than double annual revenue to about $3 billion by fiscal year end March 2018.

For the average U.S. patient, Opdivo costs about $12,500 a month, or $150,000 for a year of therapy. Bloomberg Intelligence says that consensus analyst estimates suggest that by 2020, Bristol-Myers and Ono’s Opdivo could have global sales of $9.5 billion and Merck & Co.’s Keytruda $5.1 billion.

Source: http://www.bloomberg.com/news/articles/2016-03-03/drugmaker-wins-big-in-japan-as-its-gamble-leads-to-150-000-drug

Updated 7/25/2019

From cnbc.com

https://www.cnbc.com/2019/07/24/bristol-myers-releases-mixed-opdivo-lung-cancer-results.html

Bristol-Myers releases mixed Opdivo lung cancer results

Bristol-Myers released mixed results on Wednesday from trials testing the survival benefit of its immunotherapy Opdivo in combination with either chemotherapy or its other immuno-oncology drug, Yervoy, as an initial treatment for advanced lung cancer.

The U.S. drugmaker said that Opdivo combined with chemotherapy failed to extend overall survival more than chemotherapy alone in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

The result sent Bristol-Myers shares 3% lower in extended trading, as it is likely to further solidify the domination of rival drug Keytruda from Merck as an initial treatment for advanced lung cancer, by far the most lucrative oncology market.

Both multibillion-dollar sellers are already approved for lung and several other types of cancer.

Opdivo did demonstrate an improvement in overall survival in combination with Yervoy in lung cancer patients whose tumors expressed at least 1% of the PD-L1 protein that the drug is designed to target. That accounts for about 70% of NSCLC patients, the company said.

Official company press release can be seen here:

https://news.bms.com/press-release/rd-news/bristol-myers-squibb-provides-update-part-2-checkmate-227

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that Part 2 of the Phase 3 CheckMate -227 trial did not meet the primary endpoint of overall survival (OS) with Opdivo^® (nivolumab) plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 status (HR 0.86; 95% CI 0.69-1.08). The median OS for patients treated with Opdivo plus chemotherapy was 18.83 months vs. 15.57 months for chemotherapy, and the landmark one-year OS was 67.3 percent vs. 59.2 percent, respectively. In an exploratory analysis of patients with first-line squamous NSCLC, the median OS was 18.27 months for Opdivo plus chemotherapy vs. 11.96 months for chemotherapy (HR 0.69; 95% CI 0.50-0.97). No new safety signals were observed. The company will share complete findings from this trial at an upcoming medical meeting.

“While this is not the outcome we had hoped for, the Opdivo plus chemotherapy one-year landmark overall survival in the non-squamous population was consistent with the experimental arms in previously-reported trials of IO/chemotherapy combination regimens,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. “We thank the patients and investigators who participated in this trial.”

Bristol-Myers Squibb also announced that Part 1a of the CheckMate -227 trial met the co-primary endpoint of OS, demonstrating a statistically significant benefit for Opdivo plus low-dose Yervoy^® (ipilimumab) versus chemotherapy in patients whose tumors express PD-L1 ≥1%. Additional information can be found at www.bms.com.