Tecvayli Bispecific Engager Approved by FDA for Treatment of Relapsed Myeloma; COVID-19 Subvariants Raise Concerns of Winter Surge

Week in Review
Lab technician holding vaccine vial

It’s almost the end of the week and there are significant developments and relevant news which unfolded recently—a mixed bag of good and bad news—that deserve the myeloma community’s careful attention. 

Tecvayli FDA Approval

On Wednesday, October 25, the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) announced that the FDA has approved Tecvayli™(teclistamab-cqyv) “for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody,” according to J&J’s press release

A first-in-class bispecific T-cell engager antibody, Tecvayli is administered as a subcutaneous treatment on an ongoing basis. It is wonderful to have a powerful new immune therapy added to the myeloma toolbox, especially one which is “off-the-shelf” and immediately accessible to patients. 

The approval is based upon the results of the MajesTEC-1 trial:

“The pivotal Phase 2 MajesTEC-1 clinical trial included patients who had received a median of five prior lines of therapy (n=110).1 An overall response rate (ORR) of 61.8 percent (95 percent Confidence Interval [CI]: 52.1 percent, 70.9 percent) was achieved, notably with 28.2 percent of patients achieving a complete response (CR) or better (CR or stringent complete response [sCR]). The median time to first response was 1.2 months (range 0.2 to 5.5 months). With a median follow-up of 7.4 months, the estimated duration of response (DOR) rate was 90.6 percent (95 percent CI: 80.3 percent, 95.7 percent) at six months and 66.5 percent (95 percent CI: 38.8 percent, 83.9 percent) at nine months. The study included heavily pretreated patients, and 78 percent of patients received four or more prior lines of therapy. All patients were triple-class exposed (to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody), and 76 percent were triple-class refractory (to a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody),” as elaborated by the J&J press release. 

In contrast to CAR T-cell therapies which require several weeks to prepare the engineered cells and bridging therapy to control the myeloma in the interim, Tecvayli can be directly administered to eligible patients. 

Right now, with limited access to CAR T-cell therapies, this immediate access will be tremendously helpful. 

As the third immune therapy targeting B cell maturation antigen (BCMA) after belantamab (an antibody-drug conjugate or ADC) and the CAR T-cell therapies, it will be important to assess the impact and the best sequential approaches which are now being monitored by a new IMWG immune therapy database registry.

All in all, it is greatly beneficial for myeloma patients and the myeloma community to have this new approval, especially for those who are in desperate need of an active agent. 

Moving forward, we look to refinements on how we use Tecvayli. Earlier use in the course of the disease will, hopefully, achieve even better and lasting results. 

Concerning New COVID-19 Subvariants

As we head into the winter months, concerns are mounting on another possible COVID-19 surge. New testing is revealing the presence of new subvariants derived from BA.5—the dominant strain in the most recent surge. 

According to a report from L.A. Times, BQ.1 and BQ.1.1, as well as the BA 2.75.2 subvariant are also gaining ground and their full implications are still unknown at this point.

“A few other Omicron subvariants also have risen in prominence. BQ.1.1, which some officials have pointed to as a potentially problematic strain, went from an estimated 0.2% of cases nationwide in mid-September to 7.2% this month. During that same time, BQ.1 has swelled its estimated share from 0.5% to 9.4%, while BF.7 — also known as BA. — has increased from 1.9% to 6.7%,” reports the L.A. Times. 

Another subvariant, XBB, has been reported by Business Insider to be spreading in India and Singapore—the good news is none has been detected so far in the U.S. 

According to Business Insider, “XBB is a recombinant variant – meaning that it's a combination of two other BA.2 Omicron subvariants (specifically, BA.2.10.1 + BA.2.75).” 

The subvariant XBB is “finding ways to evade the way we get immunity from vaccines and previous infection, with changes on the spike protein,” said UC Berkeley disease expert John Swartzberg to the San Francisco Chronicle.

Hopefully, the XBB strain won’t fully emerge since it does appear to evade the immune system. For now, it is important to stay alert and to keep track of COVID-19 Community Levels. 

More importantly, seek out data from wastewater analyses since this provides the best early warning of emerging new strains and the level of active infection. 

Fortunately, COVID-19 levels are still relatively low across the country. This means that slightly less stringent precautions are acceptable although myeloma patients should always be proactive in protecting themselves. It is still strongly advised to wear high-quality masks in situations where there is a great risk of exposure. 

Good News from the Scottish Peat Bogs

As a Scotsman, I am very pleased to hear that Scotland can help in the battle against climate change. Peat bogs or peat lands are like marshlands in which the soil is a dense material (called peat) which is compressed plant matter—similar to what can eventually turn into coal. Peat is used as fuel in Scotland. 

According to a report from The Guardian, “the peat is created largely from sphagnum moss and when the plant dies its remains do not fully decompose in the bog’s acid waters, and so the dead moss becomes buried and turned into peat along with its carbon contents.”

Unfortunately, water from these peat bogs is getting drained in many areas, including Sutherland where many bogs are located. When peat dries out it, releases carbon. 

Currently, a series of major projects are underway to return water to the bogs and trap carbon, as reported by BBC. These bogs could contribute as much as 30% to the carbon trapping capability globally, so there is tremendous interest in accelerating this water reclamation work. 

I am happy to see that my home country can potentially make a major contribution to fight climate change. Read this blog, to know more about Flow Country’s efforts in “repairing the damage.”

The Bottom Line

These days, there are too many things going on in the news —making it difficult to keep track of what may or may not be important. However, having a new powerful immune therapy such as Tecvayli available is clearly great news and anything that helps alleviate climate change is a blessing. My advice is to always keep a watchful eye for useful and valuable information. 

Source URL: https://www.myeloma.org/blog/tecvayli-fda-approval