Operating in a field that can leave patients with few options, Advaxis ($ADXS) rolled out data for its cervical cancer vaccine this week that represent a "meaningful step" for those afflicted, according to one expert.
In the first stage of a Phase II study of axalimogene filolisbac (ADXS-HPV), Princeton, NJ-based Advaxis said 38.5% of patients who previously failed at least one line of therapy were alive after 12 months; each was given an an estimated four to 7 months to live. However, as noted in Advaxis' release, in 17 previous studies of investigational agents conducted by the Gynecologic Oncology Group, the 12-month survival rate has never been above 30%.
|Advaxis CEO Daniel O'Connor|
Advaxis CEO Daniel O'Connor said in a statement that the data represent "some of the most encouraging Phase 2 data to date in metastatic cervical cancer," while presenter Dr. Tom Herzog said the results "are a meaningful step forward in meeting the needs of women who require second-line treatment for PRmCC." Despite the enthusiasm, the biotech's shares were down about 11% one day following the announcement.
Along with the survival data from the 26-patient study came reports of numerous adverse events. In total, 19 grade 1 or 2 adverse reactions were reported such as fatigue, chills and fever; four grade 3 adverse events such as hypotension and cytokine release syndrome; and one grade 4 event--lung infection and sepsis. As FierceBiotech notes, for patients whose cases are dire, though, regulators have allowed such reactions with the expectation that drugmakers look for ways to mitigate the events.
Investigators are now enrolling for stage 2 of the trial that'll allow for continuous cycles of treatment until disease recurrence.
Since last year, Advaxis has inked three partnerships to explore its cancer vaccine candidates in conjunction with other treatments from AstraZeneca ($AZN), Merck ($MRK) and Incyte ($INCY). Last July, it partnered with AstraZeneca to test ADXS-HPV with the pharma's MEDI4736 in HPV-related cancers. Soon after, it looked to Merck's Keytruda for a combo trial in prostate cancer with ADXS-PSA. Then, earlier this year, Advaxis joined with Incyte to pair ADXS-HPV with epacadostat for cervical cancer. To support all of the work, Advaxis raised $23 million in February through a securities purchase with institutional investors.
- here's the release
- get FierceBiotech's take