Results Summary

Patients treated at the Lentz Practice almost all suffer from late-stage metastatic cancer. Most of these patients have already failed standard of care and are immune compromised as a result. One would expect little to no clinical improvement in response to any treatment modality with patients as sick as these.

It is thus all the more remarkable that for the 10 cancer types that respond best† to OncoPherese, the Overall Response Rate (ORR) is 75.4% (average N per cancer type = 6.9). “Overall Responses” consist exclusively of Complete Responses (CR) – i.e. remission – and Partial Responses (PR) – meaning a decrease of tumor diameters of 50% or more, which is clinically very significant. Of the above Overall Responses, 42.3% were CRs and 57.7% were PRs. For the top five cancer types†† that respond best to OncoPherese, the ORR is 100%. Considering all 102 evaluable patients treated by OncoPherese – representing 25+ solid tumor cancer types – Overall Responses have been documented in 61 cases (60%).

The leading theory as to why some patients with certain metastatic cancer types respond better to OncoPherese than others is that the more responsive patients have generally received less immuno-suppressive treatment – especially chemotherapy – before reaching the Lentz Practice. However, even these lower observed responses significantly exceed what would be expected with other treatment modalities. The expected ORR to third and fourth line chemotherapies is <10% for breast and ovarian cancer, and <3% for soft tissue sarcomas, brain, melanoma, lung, colo-rectal and prostate cancers. In addition, most patients report that OncoPherese is significantly easier to withstand than chemotherapy and/or radiation.

The table below presents specific response rates for the various cancer types treated by OncoPherese at the Lentz Practice. While response rates for OncoPherese are higher than for any other treatment modality, it’s important to be aware of two key caveats:

1) Recurrence is common without maintenance treatments. While a surprising number of patients treated by OncoPherese reach full remission (CR) – defined as the absence of detectable disease – many subsequently undergo recurrence unless they undergo regular maintenance treatments. The interval before recurrence without maintenance treatments varies from a few months to several years or more, with 6-18 months being the average. The International Immunology Foundation is currently researching ways of extending the period of remission, with promising results. Fortunately, unlike chemotherapy, OncoPherese is generally effective in repeat applications. For many patients, this is a maintenance program, not a cure.

2) CBR does not equal remission. One of the data points presented below is “Combined Benefit Rate.” CBR is the total percentage of all patients who respond positively to treatment. A positive response is anything other than disease progression – everything from full remission to stable disease (i.e. not getting worse). This calculation is included because it’s popular with drug companies, given that it captures all efficacy no matter how slight and thus presents a treatment in the best possible light. For many cancer types, the Lentz Practice has documented CBRs of 100% – meaning that not a single patient with that cancer type got worse while undergoing OncoPherese. For most patients, Overall Response Rates are more meaningful.

Cancer Type	Overall Response Rate (CR+PR)			CBR
[all late stage metastatic]	# of ORs	Total N	%	%
Brain	3	3	100%	100%
Breast	20	27	74%	100%
Endometrial	1	1	100%	100%
Lung (various)	6	13	46%	100%
Melanoma	2	3	67%	100%
Ovarian	3	4	75%	100%
Prostate	8	8	100%	100%
Renal	1	1	100%	100%
Sarcoma/soft-tissue (various)	6	7	86%	100%
Sq-cell of head & neck	2	2	100%	100%

These data suggest that response rates to OncoPherese are indeed significant, but the N’s for some cancer types are too small to draw firm conclusions, and further research is therefore indicated. Additional trials are currently being planned to determine precise response rates by tumor type; time to disease progression (with and without regular maintenance treatments); duration of survival and quality of life while on treatment.

Definitions:

• CR – Complete Response: Disappearance of all measurable disease, i.e. “remission”
• PR – Partial Response: Decrease in diameters of tumors by 50% or more *
• MR – Minimal Response: Decrease in diameters of tumors by 25- 49%
• SD – Stable Disease: No increase – or decrease in diameters of tumors by <25% – while on treatment or 30 days post treatment
• PD – Progressive Disease: An increase in diameters of tumors during study or 30 days post treatment
• ORR – Overall Response Rate: The sum of the first 2 response rates above, i.e. CR+PR
• CBR – Clinical Benefit Rate: The sum of the first 4 response rates above, i.e. CR+PR+MR+SD

* All measurements are the sum of products of greatest diameters of measurable tumors.

† The 10 metastatic cancer types treated by OncoPherese with the highest documented ORR are Brain, Breast, Endometrial, Lung, Melanoma, Ovarian, Prostate, Renal, Soft-tissue Sarcomas, and Squamous cell of the head & neck. (Brain cancer – consisting of Astrocytoma II & Glioblastoma Multiforme – is included on this list although not metastatic.)

†† The top five responding metastatic cancer types – each with an ORR of 100% – are Brain, Endometrial, Prostate, Renal, and Squamous cell of the head & neck.