CR 589: Opdivo approved for mets BC

Today Bristol-Myers Squibb issued a press release announcing that Opdivo (nivolumab) has been approved by the FDA for patients with metastatic bladder cancer who have had their cancer progress after having chemotherapy. I was in the clinical trial that accrued data that led to this approval. I'm glad to hear that Opdivo is now available to mets BC patients in the clinical setting and outside of clinical trials. I hope that others have as good a response and I did.

Speaking of which, the data reveal just how fortunate I am to have had a complete response. Bristol Myers reported a 20% response rate, meaning that 1 out of 5 patients who had post-chemo stage 4 tumor growth not only had the growth stop, but reversed. Of the 270 mets BC patients enrolled in the clinical trial, 53 had clinically significant tumor shrinkage. But only 7 of the 270 had a complete response. I'm one of those seven. I am humbled and feel most fortunate. I am grateful to all the scientists and health care professionals that contributed to the development of this immunotherapy.

Unlike other drug makers who are developing checkpoint inhibitors, Bristol Myers did not limit participation in the clinical trial to those patients who showed high levels of PD-L1. Patients who had more than 1% of PD-L1 markers had a 10% better chance of having an overall response, but because PD-L1 can come and go, 15% of patients who did not test positive for PD-L1 still had an overall response.

A 20% overall response rate may seem low. But every one of those 270 patients was headed for almost certain death with active growth of metastatic tumors. I know that was the case with me. So managing to reverse the cancer in 20% of people who otherwise were on death's door is a pretty good result. The press release quotes Dr. Jonathan E. Rosenberg, MD, Memorial Sloan Kettering Cancer Center: “As an oncologist, a nearly twenty-percent response rate in advanced and metastatic bladder cancer is extremely encouraging and clinically meaningful in this patient population.” For me, it's very meaningful.

For those like me who have responded, the next question is how long the remission will last. "Among responders, the median duration of response was 10.3 months (range: 1.9⁺-12.0⁺ months)" says Bristol Myers. I'm not too worried about the median of 10.3 months, because I understand that was (and still is) an artificially shortened amount of time. Bristol Myers collected the data used for this approval in late 2015, which was about six months into my complete response. I'm now in the "12+ month" category, and the data set continues to expand for the durability data. But I also recognize that I am the data. Others will look to my experience (and many others) to help gauge how long the effect of Opdivo can last. For me, every day is a blessing.

This month, one of my term life insurance policies (a 15 year term for $500,000 in coverage) expires. I bought it back in 2002, along with a 20 year term policy and a couple of whole life policies that I was required to take by my law firm. I have the option of converting the expiring policy into a 15 year Universal Life policy with no medical underwriting, but with an annual policy cost jumping from $800 to $6200. If I was to live to age 69, my total cost for this policy would be $93,000, which is crazy expensive. But I'm thinking that it's probably a good idea to pay the $6200 a year, since the odds of my living for another 15 years are unlikely. But what do I know? When my cancer went metastatic five years ago, the odds of my surviving 5 years was less than 10%. And I'm still kicking!